SPEAKERS CONTENTS INSERTS
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29–852PS
2006
RESEARCH ON ENVIRONMENTAL AND
SAFETY IMPACTS OF NANOTECHNOLOGY:
WHAT ARE THE FEDERAL AGENCIES DOING?
HEARING
BEFORE THE
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
SEPTEMBER 21, 2006
Serial No. 109–63
Printed for the use of the Committee on Science
Available via the World Wide Web: http://www.house.gov/science
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COMMITTEE ON SCIENCE
HON. SHERWOOD L. BOEHLERT, New York, Chairman
RALPH M. HALL, Texas
LAMAR S. SMITH, Texas
CURT WELDON, Pennsylvania
DANA ROHRABACHER, California
KEN CALVERT, California
ROSCOE G. BARTLETT, Maryland
VERNON J. EHLERS, Michigan
GIL GUTKNECHT, Minnesota
FRANK D. LUCAS, Oklahoma
JUDY BIGGERT, Illinois
WAYNE T. GILCHREST, Maryland
W. TODD AKIN, Missouri
TIMOTHY V. JOHNSON, Illinois
J. RANDY FORBES, Virginia
JO BONNER, Alabama
TOM FEENEY, Florida
RANDY NEUGEBAUER, Texas
BOB INGLIS, South Carolina
DAVE G. REICHERT, Washington
MICHAEL E. SODREL, Indiana
JOHN J.H. ''JOE'' SCHWARZ, Michigan
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MICHAEL T. MCCAUL, Texas
MARIO DIAZ-BALART, Florida
BART GORDON, Tennessee
JERRY F. COSTELLO, Illinois
EDDIE BERNICE JOHNSON, Texas
LYNN C. WOOLSEY, California
DARLENE HOOLEY, Oregon
MARK UDALL, Colorado
DAVID WU, Oregon
MICHAEL M. HONDA, California
BRAD MILLER, North Carolina
LINCOLN DAVIS, Tennessee
DANIEL LIPINSKI, Illinois
SHEILA JACKSON LEE, Texas
BRAD SHERMAN, California
BRIAN BAIRD, Washington
JIM MATHESON, Utah
JIM COSTA, California
AL GREEN, Texas
CHARLIE MELANCON, Louisiana
DENNIS MOORE, Kansas
DORIS MATSUI, California
C O N T E N T S
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September 21, 2006
Witness List
Hearing Charter
Opening Statements
Statement by Representative Sherwood L. Boehlert, Chairman, Committee on Science, U.S. House of Representatives
Written Statement
Statement by Representative Bart Gordon, Minority Ranking Member, Committee on Science, U.S. House of Representatives
Written Statement
Prepared Statement by Representative Jerry F. Costello, Member, Committee on Science, U.S. House of Representatives
Prepared Statement by Representative Daniel Lipinski, Member, Committee on Science, U.S. House of Representatives
Witnesses:
Dr. Norris E. Alderson, Chair, Nanotechnology, Environmental, and Health Implications Working Group; Associate Commissioner for Science, Food and Drug Administration
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Oral Statement
Written Statement
Biography
Dr. Arden L. Bement, Jr., Director, National Science Foundation
Oral Statement
Written Statement
Biography
Dr. William H. Farland, Deputy Assistant Administrator for Science, Office of Research and Development, U.S. Environmental Protection Agency
Oral Statement
Written Statement
Dr. Altaf H. (Tof) Carim, Program Manager, Nanoscale Science and Electron Scattering Center, U.S. Department of Energy
Oral Statement
Written Statement
Biography
Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars
Oral Statement
Written Statement
Biography
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Financial Disclosure
Mr. Matthew M. Nordan, President, Director of Research, Lux Research, Inc.
Oral Statement
Written Statement
Biography
Discussion
Coordinating Federal Environmental, Health, and Safety Nanotechnology Research Programs
Regulatory Structure for University and Industry Nanomaterial Research
Is the Marketplace Outrunning Research?
Setting Priorities
Public Awareness of Nanotechnology
Appendix 1: Answers to Post-Hearing Questions
Dr. Norris E. Alderson, Chair, Nanotechnology, Environmental, and Health Implications Working Group; Associate Commissioner for Science, Food and Drug Administration
Dr. Arden L. Bement, Jr., Director, National Science Foundation
Dr. William H. Farland, Deputy Assistant Administrator for Science, Office of Research and Development, U.S. Environmental Protection Agency
Dr. Altaf H. (Tof) Carim, Program Manager, Nanoscale Science and Electron Scattering Center, U.S. Department of Energy
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Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars
Appendix 2: Additional Material for the Record
Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, September 2006
RESEARCH ON ENVIRONMENTAL AND SAFETY IMPACTS OF NANOTECHNOLOGY: WHAT ARE THE FEDERAL AGENCIES DOING?
THURSDAY, SEPTEMBER 21, 2006
House of Representatives,
Committee on Science,
Washington, DC.
The Committee met, pursuant to call, at 10:05 a.m., in Room 2318 of the Rayburn House Office Building, Hon. Sherwood L. Boehlert [Chairman of the Committee] presiding.
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HEARING CHARTER
COMMITTEE ON SCIENCE
U.S. HOUSE OF REPRESENTATIVES
Research on Environmental and
Safety Impacts of Nanotechnology:
What Are the Federal Agencies Doing?
THURSDAY, SEPTEMBER 21, 2006
10:00 A.M.–12:00 P.M.
2318 RAYBURN HOUSE OFFICE BUILDING
1. Purpose
On Thursday, September 21, 2006, the Committee on Science of the House of Representatives will hold a hearing to examine whether the Federal Government is adequately funding, prioritizing, and coordinating research on the environmental and safety impacts of nanotechnology.
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2. Witnesses
Dr. Norris E. Alderson is the Chair of the interagency Nanotechnology Environmental and Health Implications Working Group and the Associate Commissioner for Science at the Food and Drug Administration (FDA).
Dr. Arden L. Bement, Jr. is the Director of the National Science Foundation (NSF).
Dr. William Farland is the Deputy Assistant Administrator for Science in the Office of Research and Development at the Environmental Protection Agency (EPA).
Dr. Altaf H. (Tof) Carim is a Program Manager in the Nanoscale Science and Electron Scattering Center at the Office of Basic Energy Sciences in the Department of Energy (DOE).
Dr. Andrew Maynard is the Chief Science Advisor for the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars.
Mr. Matthew M. Nordan is the President and Director of Research at Lux Research Inc., a nanotechnology research and advisory firm.
3. Overarching Questions
How much is the Federal Government spending on research on environmental and safety impacts of nanotechnology? How are funding levels determined? Are current federal research efforts adequate to address concerns about environmental and safety ramifications of nanotechnology?
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What are the priorities for federally-supported research on the environmental and safety impacts of nanotechnology? How are these priorities determined, and are the current priorities appropriate?
What impacts are environmental and safety concerns having on the development of nanotechnology-related products and their entry into the marketplace? What impact might these concerns have in the future?
Are additional steps needed to improve management and coordination of federal research in this area?
4. Brief Overview
Nanotechnology, the science of materials and devices of the scale of atoms and molecules, has entered the consumer marketplace. Today, there are over 300(see footnote 1) products on the market claiming to contain nanomaterials (materials engineered using nanotechnology or containing nano-sized particles), generating an estimated $32 billion in revenue.(see footnote 2) By 2014, according to Lux Research,(see footnote 3) a private research firm that focuses on nanotechnology, there could be $2.6 trillion worth of products in the global marketplace which have incorporated nanotechnology.
There is significant concern in industry that the projected economic growth of nanotechnology could be undermined by either real environmental and safety risks of nanotechnology or the public's perception that such risks exist. Recently, some reports have indicated that these concerns are causing some companies to shy away from nanotechnology-related products and downplay nanotechnology when they talk about or advertise their products. There is an unusual level of agreement among researchers, and business and environmental organizations that the basic scientific information needed to assess and protect against potential risks does not yet exist.
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The President's fiscal year 2007 (FY07) budget requests $1.3 billion for the National Nanotechnology Initiative (NNI), the interagency nanotechnology research and development (R&D) program. Of this amount, the budget proposes $44.1 million (3.5 percent of the overall program) for research on environmental and safety implications of nanotechnology. This is $6.6 million above the FY06 funding level. Nearly 60 percent of this funding would go to NSF.
In October 2003, the White House National Science and Technology Council organized an interagency Nanotechnology Environmental and Health Implications (NEHI) Working Group, composed of agencies with research and regulatory responsibilities for nanotechnology, to coordinate environmental and safety research. The NEHI Working Group is charged with ''facilitate[ing] the identification, prioritization, and implementation of research. . .required for the responsible'' development and use of nanotechnology.(see footnote 4) The Food and Drug Administration serves as the current Chair of the NEHI Working Group.
One of the NEHI Working Group's initial tasks was developing a report describing research needs for assessing and managing the potential environmental and safety risks of nanotechnology. In March 2006, the Administration informed the Science Committee that this report would be completed that spring, but the document has not yet been released.
In July 2006, the Wilson Center's Project on Emerging Nanotechnologies released a report proposing a research strategy for ''systematically exploring the potential risks of nanotechnology.'' The report highlights critical federal research that urgently needs to be carried out in the next two years and recommends that a non-governmental organization, such as the National Academy of Sciences, develop and regularly review a long-term research strategy. The report also finds that current federal coordination does not yet have an effective mechanism to set research priorities, distribute tasks among the agencies, and ensure that adequate resources are provided for the most urgent research.
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5. Previous Science Committee Hearing
The Science Committee held a previous hearing on this topic, Environmental and Safety Impacts of Nanotechnology: What Research is Needed?, on November 17, 2005. The charter for that hearing is attached (Appendix). At that hearing, witnesses from the Federal Government, industry, and environmental organization agreed that relatively little is understood about the environmental and safety implications of nanotechnology. The non-governmental witnesses emphasized that, for the emerging field of nanotechnology to reach its full economic potential, the Federal Government must significantly increase funding for research in this area.
6. Developments Since November 2005
Fiscal Year 2007 Budget
In July 2006, the Administration released its nanotechnology supplement to the President's FY07 budget request.(see footnote 5) This document includes information about the overall funding levels for research on environment and safety impacts of nanotechnology at each of the federal agencies participating in the NNI (see Table 1). The budget supplement also provides brief descriptions of some of the activities underway in this area, and highlights FY07 initiatives such as the expansion of a joint grant program among EPA, NSF, the National Institute for Occupational Safety and Health (NIOSH) and the National Institute of Environmental Health Sciences (NIEHS), but it does not provide funding levels for specific research activities. (NIOSH is part of the Department of Health and Human Services (DHHS), and NIEHS is part of the National Institutes of Health (NIH), also part of DHHS.) To help the agencies determine how to estimate the funding levels reported in Table 1, the National Nanotechnology Coordinating Office provides a definition of ''Environment Health, and Safety Implications Research and Development (R&D),'' but the agencies' application of the definition to their programs can vary.
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Report on Federal Priorities for Research on Environmental and Safety Implications of Nanotechnology Is Not Completed
At the Science Committee's November 17, 2005 hearing on nanotechnology, Dr. Clayton Teague, Director of the National Nanotechnology Coordination Office, testified that the NEHI Working Group was ''preparing a document that identifies and prioritizes information and research needs in this area. The document will serve as a guide to the NNI agencies as they develop budgets and programs and will inform individual investigators as they consider their research directions.''(see footnote 6) In his responses to questions for the record, Dr. Teague said the report was expected to be completed by ''Spring 2006'' and ''is intended to be sufficiently detailed to guide investigators and managers in making project-level decisions, yet broad enough to provide a framework for the next five to ten years.'' The report has not yet been completed and no drafts have been released for public comment.
For the final document to provide useful guidance to agencies, Congress, industry academic researchers, environmental groups, and the public, it will need to define the scale and scope of the needed research, set priorities for research areas, provide information that can affect agency-directed spending decisions, and be specific enough to serve as overall research strategy for federal and non-federal research efforts. In the absence of such a document, each agency can only set its priorities and funding levels based on its individual mission rather than in the context of other agencies' needs or activities.
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Recent Reports
In the past year, five new reports have been published that characterize how the private sector is coping with environmental and safety implications of nanotechnology and how the Federal Government is funding and should be prioritizing its research in this area. Three of the most significant new reports are summarized below.(see footnote 7) In addition, this week the Wilson Center released the results of a national poll indicating that the majority of the public still has heard little to nothing about nanotechnology. The poll also finds that the public looks to the Federal Government and independent parties to monitor nanotechnology research and products. These findings bolster earlier calls by Congress, businesses, and environmental groups for the Federal Government to prioritize and provide more support for critical research on understanding the risks associated with nanotechnology so as to inform the public and enable the responsible development of nanotechnology.
Lux Research Report
In May 2006, Lux Research, a business research and advisory firm specializing in nanotechnology, released a report(see footnote 8) updating its May 2005 assessment(see footnote 9) of the environment and safety landscape for businesses involved with nanotechnology. According to Lux, the debate about the environmental and safety implications of nanotechnology has ''intensified,'' while the continuing lack of data, tools, and protocols for answering key safety questions is creating significant challenges for companies interested in developing nanotechnology-related products and their potential investors.
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Some large companies are shying away from nanotechnology-related products because they fear potential liabilities or the costs of extensive toxicity testing. Smaller, nanotechnology-focused companies, on the other hand, cannot leave the field, but are unable to afford to provide the data on the safety of their products increasingly requested by their customers. There are some signs that companies unsure of how to deal with potential risks may be trying to sidestep the issue by simply not using the term ''nanotechnology'' in their product descriptions.
The Lux report notes that many environmental groups have advocated for increased funding for research on the environmental and safety implications of nanotechnology and several have called for temporary or permanent moratoria on nanotechnology products. The report also suggests that regulation by agencies such as EPA, FDA, the Occupational Safety and Health Administration, and the Consumer Product Safety Commission, is in the offing, but notes that the timing and substance of regulatory action remain uncertain. Many companies have been pressing these agencies to provide information about their plans in this area and to take actions that will reduce the uncertainty surrounding regulation of nanotechnology.
Due to the uncertainty of the current research and regulatory environments, the Lux report recommends that companies develop their own plans to address potential real and perceived risks of nanomaterials and products. The Lux report does not include any recommendations for the research or regulatory agencies of the Federal Government.
Wilson Center Inventory of Research on the Environmental and Safety Impacts of Nanotechnology
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As was discussed at the Science Committee's last hearing on this topic, in 2005 the Wilson Center began assembling an inventory of ongoing research into the environmental and safety impacts of nanotechnology; the analysis of this inventory was released just after the hearing in November 2005.(see footnote 10) The inventory catalogs research funded by governments around the world as well as some research funded by industry and foundations. The primary purpose of the inventory is to facilitate strategic, coordinated and integrated research among the public and private sectors on research in this area. While the inventory is not complete, it includes all the available public information on federally-sponsored research.
The Wilson Center's initial analysis(see footnote 11) of the inventory highlights two main points. The first is that significant gaps exist in the current portfolio of federally supported research projects. For example, the Wilson Center found few projects focused on controlling or preventing exposure to engineered nanomaterials and their release into the environment, as well as little research into the diseases and environmental impacts that may result from exposure. While there were many research projects studying the hazards of exposure to nanoparticles, most research focused on the lungs, with no projects focusing on the gastrointestinal tract. The Wilson Center's research needs report, described in the next section, suggests that these gaps in the research portfolio may reflect the absence of an overall federal strategy for conducting research on the environmental and safety impacts of nanotechnology.
The second main finding of the analysis is the inconsistency between the Wilson Center inventory and the federal budget supplement. The Wilson Center found $31 million worth of research projects funded by the U.S. Government in 2005 that had some relevance to the potential environmental and safety risks of nanotechnology. However, only $11 million of the $31 million was going to projects that specifically focused on the environmental or safety implications of nanotechnology. In contrast, the FY07 NNI budget supplement states that, in FY05, the federal agencies in NNI spent $35 million on research for which the primary purpose was understanding and addressing potential environmental and safety risks of nanotechnology. The Wilson Center inventory includes the available public information on federally sponsored research, and since the NNI has not developed its own detailed inventory of projects in this area, it is not currently possible to determine why these accountings differ.
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Wilson Center, ''Nanotechnology: A Research Strategy for Addressing Risk''
In July 2006, Dr. Andrew Maynard, the Wilson Center's Chief Scientist, and a former NIOSH scientist, proposed a research strategy for ''systematically exploring the potential risks of nanotechnology.''(see footnote 12) Based on the significant knowledge gaps identified in a variety of research needs reports from federal agencies, private groups, and international bodies; the Wilson Center's inventory of research in this area; his own experience in interagency activities while at NIOSH; and a risk-based framework that he developed, the report outlines the highest priority areas of research in which investment is needed between 2007 and 2009 to ensure the safety of technologies in use or close to commercialization and lay the groundwork for future research needs. The highest short-term priorities include identifying and measuring exposure and environmental releases, assessing toxicity, controlling releases, and developing best practices for worker safety, while longer-term needs include investment in areas such as predictive toxicology, the ability to predict the toxicological effects of nanomaterials.
The report also makes recommendations for changes in federal nanotechnology programs to ensure that the appropriate investments are made and the programs are carried out effectively. First, the report calls for the Federal Government to shift funding for research on environmental and safety impacts of nanotechnology to those federal agencies with clear mandates and expertise in risk-related research, including EPA, NIOSH, NIEHS, and NIST, and the analysis in the report suggests that these agencies will require a minimum of $100 million over the next two years to carry out the needed research. The report also expresses concern that the current interagency process is insufficient and that gaps in the research portfolio are resulting from a bottom-up approach in which each agency develops its own research priorities. The report therefore recommends the establishment of a new interagency oversight group with the ''authority to set and implement a strategic research agenda'' and to assure adequate resources for those agencies carrying out the highest priority research.
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The report also recommends that the Federal Government work closely with outside groups in executing research in this area. It says that mechanisms are needed to facilitate government-industry research partnerships and to enable international collaboration and information sharing. It cites the Health Effects Institute, an organization that has effectively addressed controversial air pollution research through joint government and private sector funding, as an excellent model for what is needed.(see footnote 13) It also calls for international cooperation to share research costs and exchange information.
The report also calls for a long-term research strategy to be developed and reviewed regularly by an organization such as the National Academies. This recommendation is consistent with the recommendation made by Dr. Richard Denison, of the environmental organization Environmental Defense, in his testimony before the committee at the November 17, 2005 hearing.
7. Witness Questions
Questions for Dr. Norris Alderson, Food and Drug Administration
In your testimony, please briefly describe the responsibilities and activities of the National Nanotechnology Environmental and Health Implications (NEHI) Working Group and address the following questions:
What are the overall priorities for federally-supported research on the environmental and safety impacts of nanotechnology and how are these priorities determined? To what extent is the NEHI Working Group involved in setting or recommending funding levels for research in these areas? How are research roles allocated among the different agencies? How are ongoing research activities coordinated?
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When will the federal report that describes research needs for assessing and managing the potential risks of nanotechnology be completed and released? How is the NEHI Working Group incorporating information about risk and about the research needs of federal regulatory activities into the research needs document? How is input from groups outside of government, including industry, incorporated?
What topics will the report cover and what issues will remain to be addressed in the future? What will be the responsibilities and activities of the NEHI Working Group once the report is complete?
Questions for Dr. Arden Bement, National Science Foundation
In your testimony, please briefly describe NSF's current and proposed fiscal year 2007 programs and funding for research on possible environmental and safety risks associated with nanotechnology, and address the following questions:
What are your agency's research priorities for studies of environmental and safety impacts of nanotechnology? How were these priorities determined, and what would cause them to change? To what extent is your research agenda specifically designed to inform potential regulation? How have you decided what portion of your nanotechnology funding to allocate to research in this area?
In what specific ways has your agency's research agenda been shaped by interagency coordination? Are there areas of research you are conducting because they have not been taken up by other agencies or areas that you are forgoing because other agencies are taking on that research? Is there research being done because of the specific needs of regulatory agencies?
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Questions for Dr. William Farland, Environmental Protection Agency
In your testimony, please briefly describe EPA's current and proposed fiscal year 2007 programs and funding for research on possible environmental and safety risks associated with nanotechnology and address the following questions:
What are your agency's research priorities for studies of environmental and safety impacts of nanotechnology? How were these priorities determined, and what would cause them to change? To what extent is your research agenda specifically designed to inform potential regulation? How have you decided what portion of your research funding to allocate to nanotechnology-related projects?
In what specific ways has your agency's research agenda been shaped by interagency coordination? Are there areas of research you are conducting because they have not been taken up by other agencies or areas that you are forgoing because other agencies are taking on that research? Is there research being done because of the specific needs of regulatory agencies?
Questions for Dr. Altaf (Tof) Carim, Department of Energy
In your testimony, please briefly describe the Department of Energy's current and proposed Fiscal Year 2007 (FY07) programs and funding for research on possible environmental and safety risks associated with nanotechnology and address the following questions:
What are your agency's research priorities for studies of environmental and safety impacts of nanotechnology? How were these priorities determined, and what would cause them to change? To what extent is your research agenda specifically designed to inform potential regulation? How have you decided what portion of your nanotechnology funding to allocate to research in this area?
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In what specific ways has your agency's research agenda been shaped by interagency coordination? Are there areas of research you are conducting because they have not been taken up by other agencies or areas that you are forgoing because other agencies are taking on that research? Is there research being done because of the specific needs of regulatory agencies?
Questions for Dr. Andrew Maynard, Project on Emerging Nanotechnologies, Woodrow Wilson Center
In your testimony, please briefly describe the results of the Wilson Center's inventory of federal research on the environmental and safety impacts of nanotechnology and the report, ''Nanotechnology: A Research Strategy for Addressing Risk?'', and address the following questions:
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? Are there gaps in the portfolio of federal research currently underway; if so, in what areas?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? How should the responsibility for funding and conducting this research be divided among the federal agencies, industry, and universities?
What elements should the forthcoming report on research needs produced by the National Nanotechnology Environmental and Health Implications Working Group contain to adequately guide federal research investment in this area? What additional steps are needed to improve management and coordination of federal research on the environmental and safety impacts of nanotechnology?
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Questions for Mr. Matthew Nordan, Lux Research
Please address the following questions in your testimony:
What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? How should the responsibility for funding and conducting this research be divided among the federal agencies, industry, and universities?
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? Are there gaps in the portfolio of federal research currently underway; if so, in what areas?
What additional steps are needed to improve management and coordination of the Federal Government's research enterprise?
Appendix: Hearing Charter from November 17, 2005 Hearing on Environmental and Safety Impacts of Nanotechnology: What Research is Needed?
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HEARING CHARTER
COMMITTEE ON SCIENCE
U.S. HOUSE OF REPRESENTATIVES
Environmental and Safety
Impacts of Nanotechnology:
What Research Is Needed?
THURSDAY, NOVEMBER 17, 2005
10:00 A.M.–12:00 P.M.
2318 RAYBURN HOUSE OFFICE BUILDING
1. Purpose
On Thursday, November 17, 2005, the Committee on Science of the House of Representatives will hold a hearing to examine current concerns about environmental and safety impacts of nanotechnology and the status and adequacy of related research programs and plans. The Federal Government, industry and environmental groups all agree that relatively little is understood about the environmental and safety implications of nanotechnology and that greater knowledge is needed to enable a nanotechnology industry to develop and to protect the public. The hearing is designed to assess the current state of knowledge of, and the current research plans on the environmental and safety implications of nanotechnology.
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2. Witnesses
Dr. Clayton Teague is the Director of the National Nanotechnology Coordination Office, the office that coordinates federal nanotechnology programs. The office is the staff arm of the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council (NSTC). NSTC includes all federal research and development (R&D) agencies and is the primary coordination group for federal R&D policy.
Mr. Matthew M. Nordan is the Vice President of Research at Lux Research Inc., a nanotechnology research and advisory firm.
Dr. Krishna C. Doraiswamy is the Research Planning Manager at DuPont Central Research and Development, and is responsible for coordinating DuPont's nanotechnology efforts across the company's business units.
Mr. David Rejeski is the Director of the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars.
Dr. Richard Denison is a Senior Scientist at Environmental Defense.
3. Overarching Questions
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
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What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? If not, what additional steps are necessary?
4. Brief Overview
Nanotechnology is expected to become a major engine of economic growth in the coming years. According to Lux Research,(see footnote 14) a private research firm that focuses on nanotechnology, in 2014 there could be $2.6 trillion worth of products in the global marketplace which have incorporated nanotechnology—15 percent of manufacturing output. Lux also predicts that in 2014, 10 million manufacturing jobs worldwide—11 percent of total manufacturing jobs—will involve manufacturing these nanotechnology-enabled products.
There is a growing concern in industry that the projected economic growth of nanotechnology could be undermined by real environmental and safety risks of nanotechnology or the public's perception that such risks exist.
The small size, large surface area and unique behavioral characteristics of nanoparticles present distinctive challenges for those trying to assess whether these particles pose potential environmental risks. For example, nanoscale materials such as buckyballs, nano-sized clusters of carbon atoms, behave very differently than their chemically-equivalent cousin, pencil lead. There is an unusual level of agreement among researchers, and business and environmental organizations that basic scientific information needed to assess and protect against potential risks does not yet exist.
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In December 2003, the President signed the 21st Century National Nanotechnology Research and Development Act (P.L. 108–153), which originated in the Science Committee. This Act provided a statutory framework for the interagency National Nanotechnology Initiative (NNI). Among other activities, the Act called for the NNI to ensure that research on environmental concerns is integrated with broader federal nanotechnology research and development (R&D) activities.
Federal funding for the NNI has grown from $464 million in fiscal year 2001 (FY01) to a requested $1.1 billion in FY06. Of the requested FY06 level, the President's budget proposes that $38.5 million (four percent of the overall program) be directed to research on environmental and safety implications of nanotechnology.
5. Background
The National Academy of Sciences describes nanotechnology as the ''ability to manipulate and characterize matter at the level of single atoms and small groups of atoms.'' An Academy report describes how ''small numbers of atoms or molecules. . .often have properties (such as strength, electrical resistivity, electrical conductivity, and optical absorption) that are significantly different from the properties of the same matter at either the single-molecule scale or the bulk scale.''(see footnote 15)
Nanotechnology is an enabling technology that will lead to ''materials and systems with dramatic new properties relevant to virtually every sector of the economy, such as medicine, telecommunications, and computers, and to areas of national interest such as homeland security.''(see footnote 16) As an enabling technology, it is expected to be incorporated into existing products, resulting in new and improved versions of these products. Some nanotechnology-enabled products are already on the market, including stain-resistant, wrinkle-free pants, ultraviolet-light blocking sun screens, and scratch-free coatings for eyeglasses and windows. In the longer run, nanotechnology may produce revolutionary advances in a variety of industries, such as faster computers, lighter and stronger materials for aircraft, more effective and less invasive ways to find and treat cancer, and more efficient ways to store and transport electricity.
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The projected economic growth of nanotechnology is staggering. In October 2004, Lux Research, a private research firm, released its most recent evaluation of the potential impact of nanotechnology. The analysis found that, in 2004, $13 billion worth of products in the global marketplace incorporated nanotechnology. The report projected that, by 2014, this figure will rise to $2.6 trillion—15 percent of manufacturing output in that year. The report also predicts that in 2014, ten million manufacturing jobs worldwide—11 percent of total manufacturing jobs—will involve manufacturing these nanotechnology-enabled products.(see footnote 17)
6. How Might Environmental and Safety Risks Affect the Commercialization of Nanotechnology?
Lux Research Report on Environmental and Safety Risks of Nanotechnology
In May, 2005, Lux Research published a comprehensive analysis of how environmental and safety risks could affect the commercialization of nanotechnology.(see footnote 18) While a limited number of studies have been done on specific environmental impacts, the report concludes that the few that have been done raise sufficient cause for concern. This leads to what the report calls a fundamental paradox facing companies developing nanotechnology: ''They must plan for risks without knowing precisely what they are.'' The report then identifies two classes of risk that are expected to effect commercialization: ''real risks that nanoparticles may be hazardous and perceptual risks that they pose a threat regardless of whether or not it is real.'' The report calculates that at least 25 percent of the $8 trillion in total projected revenue from products incorporating nanotechnology between 2004 and 2014 could be affected by real risks and 38 percent could be affected by perceived risk.''
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The report describes that varying levels of risk are suspected for different types of nanomaterials and products and for different phases of a product's life cycle. For example, some nanoclay particles raise little initial concern because they would be locked up in composites to be used in automotive bodies. On the other hand, cadmium-selenide quantum dots that could be injected into the body for medical imaging tests are highly worrisome due to the toxicity of cadmium-selenide and the fact that they would be used within the human body.
Another factor that contributes to the potential risk of different nanotechnology-related products is the expected exposure of people and the environment over the product's life cycle.
The manufacturing phase is the first area of concern because workers potentially face repeated exposure to large amounts of nanomaterials.(see footnote 19) During product use, the actual risk will vary depending in part on whether the nanoparticles have been fixed permanently in a product, like within a memory chip in a computer, or are more bio-available, like in a sun screen where exposure may be more direct or may continue over a long period of time. Finally, the greatest uncertainties exist about the risks associated with the end of a product's life because it is difficult to predict what method of disposal, such as incineration or land disposal, will be used for a given material, and there has been little research on, for example, what will happen to nanomaterials within products stored in a landfill over 100 years.
The Lux Research report finds that nanotechnology also faces significant perceived risks. These risks are driven by people's general concerns about new technologies that they may be exposed to without being aware of it. However, public perceptions of nanotechnology are still up in the air and may be influenced by the press and non-governmental organizations. The report argues that, with a concerted effort to emphasize the benefits of nanotechnology, communicate honest assessments of toxicological effects, and engage all interested stakeholders from the outset, the public could be made comfortable with this new technology.
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Woodrow Wilson International Center Study on Public Perceptions
A more in-depth survey of public perception of nanotechnology was recently completed by Woodrow Wilson Center's Project on Emerging Technologies.(see footnote 20) The study found that the public currently has little knowledge about nanotechnology or about how risks from nanotechnology will be managed. This lack of information can lead to mistrust and suspicion. However, the study shows that when people learned more about nanotechnology and its promised benefits, approximately 80 percent were supportive or neutral about it. Once informed, people also expressed a strong preference for having more information made available to the public, having more testing done before products were introduced, and having an effective regulatory system. They do not trust voluntary approaches and tend to be suspicious of industry. The lesson, according to the report, is that there is still time to shape public perception and to ensure that nanotechnology is developed in a way that provides the public with information it wants and establishes a reasonable regulatory framework.
7. Emerging Environmental and Safety Concerns
Initial research on the environmental impacts of nanotechnology has raised concerns. For example, early research on buckyballs (nano-sized clusters of 60 carbon atoms) suggests that they may accumulate in fish tissue. Although it may turn out that many, if not most, nanomaterials will be proven safe in and of themselves and within a wide variety of products, more research is needed before scientists can determine how they will interact with people and the environment in a variety of situations.
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Nanotechnology's potential to affect many industries stem from that fact that many nanoscale materials behave differently than their macroscale counterparts. For example, nano-sized quantities of some electrical insulating materials become conductive, insoluble substances may become soluble, some metals become explosive, and materials may change color or become transparent. These novel features create tremendous opportunities for new and exciting applications, but also enable potentially troubling new ways for known materials to interact with the human body or be transported through the environment. It is difficult and would be misleading to extrapolate from current scientific knowledge on how materials behave in their macro-form to how they will behave in nano-form, and new techniques to assess toxicity, exposure, and ultimately public and environmental risks from these materials may be needed.
Widely Recognized Research and Development Needs
Businesses, non-governmental organizations, academic researchers, federal agencies, and voluntary standards organizations all have efforts underway to address concerns about the environmental and safety implications of nanotechnology. However, a number of organizations, including business associations and environmental groups, worry that environmental R&D is not keeping pace with the rapid commercialization and development of new nanotechnology-related products. There is widespread agreement on the following research and standards needs:
Nanotechnology needs an accepted nomenclature. For example, ''buckyballs'' is the equivalent of a trade name; it does not convey critical information about the content, structure, or behavior of nanoparticles as traditional chemical nomenclature does for traditional chemicals. The lack of nomenclature creates a variety of problems. For example, it is difficult for researchers to know whether the nanomaterial they are working with is the same as that presented in other research papers. Similarly, it is difficult for a company to know whether it is buying the same nanomaterial from one company that it previously bought from another.
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Nanotechnology needs an agreed upon method for characterizing particles. Nanoparticles unique size enables unusual behavior. At these small sizes, particles can have different optical and electrical properties than larger particles of the same material. In addition, the large surface area of nanoparticles relative to their mass makes nanoparticles more reactive with their surroundings. Further complicating efforts to characterize nanomaterials is that small changes to some nanoparticles, such as altering the coatings of buckyballs, significantly modify the physical properties (and hence the potential toxicity) of the particles.
A great deal more information is needed on the mechanisms of nanoparticle toxicity. Early studies suggest that a variety of nanoparticles damage cells through oxidative stress. (Oxidation is believed to be a common source of many diseases such as cancer.) A better understanding of the chemical reactions that nanoparticles provoke or take part in within living organisms will enable researchers to more effectively predict which nanomaterials are most likely to cause problems.
Basic information on how nanomaterials enter and move through the human body are needed. Early studies point to wide variations in the toxicity of nanomaterials depending on the how exposure occurred—through the mouth, skin contact, inhalation, or intravenously. Particles in the range of 1–100 nanometers are small enough to pass through cell walls and through the blood-brain barrier, making them particularly mobile once they enter the body. There is also concern that some nanoparticles could lodge in the lungs and might be so small as to be overlooked by the body's defense mechanisms that would normally remove these invaders from the body.
More research is needed on how and why some nanoparticles appear to behave one way as individual particles, but behave differently when they accumulate or agglomerate. One study of buckyballs, for example, found that while individual buckyballs are relatively insoluble, they have a tendency to aggregate, which makes them highly soluble and reactive with bacteria, raising concerns about their transport in watersheds and their impact on ecosystems.
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According to a variety of experts, many of whom are familiar with the development of the largely mature databases available on the behavior and toxicity of various chemicals, development of a parallel collection of information on nanotechnology-related materials may take as long as 10–15 years.
Call for a Governmental Program on Environmental and Safety Implications of Nanotechnology
Recently, the American Chemistry Council and the environmental organization, Environmental Defense, agreed on a Joint Statement of Principles that should guide a governmental program for addressing the potential risks of nanoscale materials.(see footnote 21) They call for, among other things,
''a significant increase in government investment in research on the health and environmental implications of nanotechnology,''
''the timely and responsible development of regulation of nanomaterials in an open and transparent process,''
''an international effort to standardize test protocols, hazard and exposure assessment approaches and nomenclature and terminology,''
''appropriate protective measures while more is learned about potential human health or environmental hazards,'' and
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a government assessment of ''the appropriateness of or need for modification of existing regulatory frameworks.''
8. Federal Government Activities
The National Nanotechnology Initiative (NNI) is a multi-agency research and development (R&D) program begun in 2001 and formally authorized by Congress in 2003.(see footnote 22) Currently, 11 federal agencies have ongoing programs in nanotechnology R&D, while another 11 agencies participate in the coordination and planning work associated with the NNI. The primary goals of the NNI are to foster the development of nanotechnology and coordinate federal R&D activities.(see footnote 23)
Federal funding for the NNI has grown from $464 million in FY01 to a requested $1.1 billion in FY06. Of the requested FY06 level, the President's budget proposes that $38.5 million (four percent of the overall program) be directed to research on environmental, health, and safety implications of nanotechnology (see Table 1).(see footnote 24)
29852d.eps
To coordinate environmental and safety research on nanotechnology, the National Science and Technology Council organized in October 2003 the interagency Nanotechnology Environmental and Health Implications Working Group (NEHI WG), composed of agencies that support nanotechnology research as well as those with responsibilities for regulating nanotechnology-based products. NEHI WG is in the process of developing a framework for environmental R&D for nanotechnology that it expects to release in January 2006. To provide useful guidance to agencies, Congress, academic researchers, industry, environmental groups, and the public, the research framework will need to define the scale and scope of the needed research, set priorities for research areas, provide information that can affect agency-directed spending decisions, and be specific enough to serve as overall research strategy for federal and non-federal research efforts.
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Currently, over 60 percent of the environmental research funding is provided by the National Science Foundation (NSF). In FY05 and FY06, NSF is putting a small amount of funding (approximately $1 million each year) into a joint solicitation on investigating environmental and human health effects of manufactured nanomaterials with the Environmental Protection Agency, the National Institute for Occupational Safety and Health (NIOSH), and National Institute of Environmental Health Sciences (NIEHS). However, the majority of the NSF's funding in this area is distributed to projects proposed in response to general calls for nanotechnology-related research; projects are selected based on the quality and potential impact of the proposed research. It is not distributed based on the research needs of regulatory agencies such as EPA, OSHA or FDA. Currently NSF and the research community base their understanding of priorities in environmental research on a 2003 workshop ''Nanotechnology Grand Challenge in the Environment,''(see footnote 25) but the federal framework being developed by the NEHI WG should provide helpful, updated guidance for future research solicitations and proposals.
EPA's Office of Research and Development is the second largest sponsor of research on the environmental implications of nanotechnology, providing approximately 10 percent ($4 million) of the federal investment. At the beginning of the NNI, EPA focused its research program on the development of innovative applications of nanotechnology designed to improve the environment, but in FY03, EPA began to shift its focus to research on the environmental implications of nanotechnology. In FY04 and FY05, EPA has increasingly tailored its competitive solicitations to attract research proposals in areas that will inform decisions to be made by the agency's regulatory programs. In January 2006, EPA is planning to release an agency-wide nanotechnology framework that will describe both the potential regulatory issues facing the agency and the research needed to support decisions on those issues.
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NIOSH sponsors eight percent ($3 million) of research on environmental and safety implications of nanotechnology, and its activities are driven by the fact that minimal information is currently available on dominant exposure routes, potential exposure levels and material toxicity. NIOSH is attempting fill those gaps by building on its established research programs on ultra-fine particles (typically defined as particles smaller than 100 nanometers). The National Toxicology Program, an interagency collaboration between NIOSH and NIEHS, also supports a portfolio of projects studying the toxicity of several common nanomaterials, including quantum dots, buckyballs, and the titanium dioxide particles that have been used in cosmetics. NIOSH published a draft research strategy in late September 2005.
Private Sector Research
There is little information about how much individual companies are investing in research on the environmental and safety implications of nanotechnology. There are, however, a variety of activities underway in industry associations emphasizing the importance of research in this area. Members of the American Chemistry Council's ChemStar panel, for example, have committed to ensuring that the commercialization of nanomaterials proceeds in ways that protect workers, the public and the environment. Other elements of the chemical and semiconductor industries have formed the Consultive Boards for Advancing Nanotechnology, which has developed a list of key research and evaluation, identifying toxicity testing, measurement, and worker protection.
Potential Regulatory and Policy Issues.
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Some companies, especially large firms that operate in many industry sectors, have significant experience dealing with environmental issues and risk management plans, are comfortable dealing with potential environmental and safety implications arising from nanotechnology. However, many companies that are involved with nanotechnology-related products are small, start-up companies or small laboratories with less experience in this area. According to the Lux Research report described above, some of these small enterprises do not carry out testing because they lack the resources to do so, while others do not do so because of fear they might learn something that could create legal liability or create barriers to commercializing their product.
At EPA, the regulatory program offices are trying to determine whether and to what degree existing regulatory programs can and should be applied to nanotechnology. For example, EPA is considering how the Toxic Substances Control Act (TSCA) will apply to nanotechnology, having recently approved the first nanotechnology under that statute. (See Appendix A for a recent Washington Post article discussing the issue). Enacted in 1976, TSCA authorizes EPA to regulate new and existing chemicals and provides EPA with an array of tools to require companies to test chemicals and adopt other safeguards. Decisions on conventional chemicals under TSCA are driven by a chemical's name, test data, and models of toxicity and exposure. Because much of this information does not yet exist for nanotechnology, EPA is having a difficult time deciding how best to proceed. The lack of information led to EPA's recent proposal to create a voluntary program under which companies would submit information that would help the agency learn about nanotechnology more quickly. EPA is now evaluating all of its water, air and land regulatory responsibilities to determine whether and how EPA should handle nanotechnology in these areas.
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Other federal agencies with regulatory responsibilities, such as the Food and Drug Administration and the Occupational Safety and Heath Administration, are also trying to determine how they will address environmental and safety concerns related to nanotechnology.
A number of observers, including the United Kingdom's Royal Society,(see footnote 26) have suggested a precautionary approach to nanotechnology until more research has been completed. They urge caution especially regarding applications in which nanoparticles will be purposely released into environment. Examples of these so-called dispersive uses are nanomaterials used to clean contaminated groundwater or those that when discarded enter the sewer system and thereby the Nation's waterways.
9. Witness Questions
The witnesses were asked to address the following questions in their testimony:
Questions for Dr. Clayton Teague
In your testimony, please briefly describe current federal efforts to address possible environmental and safety risks associated with nanotechnology and address the following questions:
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
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What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
How much is the Federal Government spending for research on environmental and safety implications of nanotechnology? Which agencies have the lead? What additional steps are needed?
Questions for Mr. Matthew Nordan
In your testimony, please briefly describe the major findings of the Lux Research report on environmental and safety issues associated with nanotechnology and address the following questions:
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
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Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? If not, what additional steps are necessary?
Questions for Dr. Krishna Doraiswamy
In your testimony, please briefly describe what DuPont is doing to address possible environmental and safety risks associated with nanotechnology and answer the following questions:
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? If not, what additional steps are necessary?
Questions for Mr. David Rejeski
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In your testimony, please briefly describe the major findings of the Wilson Center's recent study on public perceptions about nanotechnology and answer the following four questions:
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? If not, what additional steps are necessary?
Questions for Dr. Richard Denison
What impacts are environmental and safety concerns having on the development and commercialization of nanotechnology-related products and what impact might these concerns have in the future?
What are the primary concerns about the environmental and safety impacts of nanotechnology based on the current understanding of nanotechnology?
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What should be the priority areas of research on environmental and safety impacts of nanotechnology? Who should fund and who should conduct that research?
Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? If not, what additional steps are necessary?
Appendix A
Nanotechnology's Big Question: Safety
Some Say Micromaterials Are Coming to Market Without Adequate Controls
THE WASHINGTON POST
OCTOBER 23, 2005, PAGE A11
BY JULIET EILPERIN, WASHINGTON POST STAFF WRITER
With little fanfare, the Environmental Protection Agency has for the first time ruled on a manufacturer's application to make a product composed of nanomaterials, the new and invisibly small particles that could transform the Nation's engineering, industrial and medical sectors.
The agency's decision to approve the company's plan comes amid an ongoing debate among government officials, industry representatives, academics and environmental advocates over how best to screen the potentially toxic materials. Just last week, a group of academics, industry scientists and federal researchers, working under the auspices of the nonprofit International Life Sciences Institute, outlined a set of principles for determining the human health effects of nanomaterial exposures.
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By year-end, the EPA plans to release a proposal on how companies should report nanomaterial toxicity data to the government.
''Toxicity studies are meaningless unless you know what you're working with,'' said Andrew Maynard, who helped write the institute's report and serves as chief science adviser to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, a Washington-based think tank.
Because of their tiny size, nanomaterials have special properties that make them ideal for a range of commercial and medical uses, but researchers are still trying to determine how they might affect humans and animals. Gold, for example, may behave differently when introduced at nanoscale into the human body, where it is chemically inert in traditional applications.
The institute's report urged manufacturers and regulators to evaluate the properties of nanomaterials in laboratory tests, adding: ''There is a strong likelihood that the biological activity of nanoparticles will depend on physiochemical parameters not routinely considered in toxicology studies.''
The EPA decided last month to approve the ''pre-manufacture'' of carbon nanotubes, which are hollow tubes made of carbon atoms and potentially can be used in flat-screen televisions, clear coatings and fuel cells. The tubes, like other nanomaterials, are only a few ten-thousandths the diameter of a human hair.
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Jim Willis, who directs the EPA's chemical control division in the Office of Pollution Prevention and Toxics, said he could not reveal the name of the company that received approval for the new technology or describe how that technology might be marketed. He added, however, that the EPA reserved the right to review the product again if the company ultimately decides to bring it to market.
Nanomaterials are already on the market in cosmetics, clothing and other products, but these items do not fall under the EPA's regulatory domain. EPA officials judge applications subject to the Toxic Substances Control Act (TOSCA), a law dating from the mid-1970s that applies to chemicals.
In a Wilson Center symposium last Thursday, Willis said ''it is a challenge'' to judge nanotechnology under existing federal rules.
''Clearly, [TOSCA] was not designed explicitly for nanoscale materials,'' he said, but he added that chemicals ''have quite a number of parallels for nanoscale materials'' and that ''in the short-term, we are going to learn by doing.''
Scientific studies also suggest nanoparticles can cause health problems and damage aquatic life. For instance, they lodge in the lungs and respiratory tract and cause inflammation, possibly at an even greater rate than asbestos and soot do.
''Nanoparticles are like the roach motel. The nanoparticles check in but they don't check out,'' said John Balbus, health program director for the advocacy group Environmental Defense. ''Part of this is a societal balancing act. Are these things going to provide such incredible benefits that we're willing to take some of these risks?''
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Nanomaterials have possible environmental advantages as well. For instance, they can absorb pollutants in water and break down some harmful chemicals much more quickly than other methods.
''Just because something's nano doesn't mean it's necessarily dangerous,'' said Kevin Ausman, Executive Director of Rice University's Center for Biological and Environmental Nanotechnology. He added that when it comes to nanotechnology's toxic effects, ''we're trying to get that data before there's a known problem, and not after there's a known problem.''
Companies such as DuPont are pushing to establish nanotechnology safety standards as well, in part because they have seen how uncertainties surrounding innovations—such as genetically modified foods—have sparked a backlash among some consumers.
''The time is right for this kind of collaboration,'' said Terry Medley, DuPont's Global Director of corporate regulatory affairs. ''There's a general interest on everyone's part to come together to decide what's appropriate for this technology.''
Chairman BOEHLERT. I want to welcome everyone to this important hearing on a subject that has been a matter of continuing concern to this committee.
As our hearing last fall on this subject brought home, a great deal is at stake in setting a research agenda on the environmental and safety consequences of nanotechnology. I am still out of breath. The nanotechnology industry, which has enormous economic potential, will be stymied if the risks of nanotechnology are not clearly understood and addressed. And, of course, the potential danger to human beings and the environment is literally incalculable if we don't understand how nanotechnology can interact with our bodies and our world. That is why there is unusual agreement among every sector—business, government, environmental advocacy groups—that we need to get a handle on this issue. Our witnesses will underscore these basic points again today.
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There is also broad agreement, I think, about what the government has to do to protect both the public and business. The government needs to establish and implement a clear, prioritized research agenda and fund it adequately. The problem is that we still haven't done that, and ''time is a wasting.''
The federal agencies have made some steps in the direction of setting an agenda, which, admittedly, is a difficult process. I am pleased that the long-delayed interagency report on research needs is finally being released at, and dare I say, because of, our hearing today. But as that document itself states, it is only a first step, and it doesn't fully set priorities, never mind assign them. So we are on the right path to dealing with the problem, but we are sauntering down it at a time when a sense of urgency is required.
The second problem, of course, is that environmental research on nanotechnology is grossly under-funded. Conservative estimates of what is needed are more than twice as much as we are spending today. This is ''penny wise and pound foolish,'' to put it mildly, given what nanotechnology could contribute to our economy and what health problems from nanotechnology could detract from it.
So I hope that our discussion today can infuse everyone here, including the media and the public, with a sense of urgency about this problem. We need to come up with a mechanism in which priorities will be set for, assigned to, and actually carried out by the responsible federal agencies. Current coordinating mechanisms clearly are inadequate, and I hope we can have a good discussion today of what to do to replace that current mechanism.
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I know that diversity is a source of strength in our research establishment, and I am not one who believes that duplication is always a bad thing. But we have to bring some order to this process or we are going to squander our chance to understand nanotechnology on a schedule that will help business and protect the public.
So I look forward to hearing from our witnesses today, and I can assure them we will be following up on this. At the very least, until the day I leave this chair in this institution Dec. 31, and hopefully long past that.
Let me just address a couple of protocol matters before I turn to Mr. Gordon.
First, I am going to try to keep witnesses and Members to their five minutes, because we have a huge panel and votes may occur as early as 11:30. Second, let me say that normally, we would have Dr. Bement testify first, as the highest-ranking official on the panel, but we wanted to hear first from the official who is chairing the interagency effort to get some perspective. Finally, I understand that Mr. Farland has announced his retirement, and I want to thank him for his years of helping this committee and for serving the public. That is something we both have announced: our retirement. We will go forth together.
With that, let me turn to Mr. Gordon.
[The prepared statement of Chairman Boehlert follows:]
PREPARED STATEMENT OF CHAIRMAN SHERWOOD L. BOEHLERT
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I want to welcome everyone to this important hearing on a subject that has been a matter of continuing concern to this committee.
As our hearing last fall on this subject brought home, a great deal is at stake in setting a research agenda on the environmental and safety consequences of nanotechnology. The nanotechnology industry, which has enormous economic potential, will be stymied if the risks of nanotechnology are not clearly understood and addressed. And, of course, the potential danger to human beings and the environment is literally incalculable if we don't understand how nanotechnology can interact with our bodies and our world. That's why there's unusual agreement among every sector—business, government, environmental advocacy groups—that we need to get a handle on this issue. Our witnesses will underscore these basic points again today.
There's also broad agreement, I think, about what the government has to do to protect both the public and business. The government needs to establish and implement a clear, prioritized research agenda and fund it adequately. The problem is that we still haven't done that, and ''time's a wasting.''
The federal agencies have made some steps in the direction of setting an agenda, which, admittedly, is a difficult process. I'm pleased that the long-delayed interagency report on research needs is finally being released at—and dare I say, because of—our hearing today. But as that document itself states, it's only a first step, and it doesn't fully set priorities, never mind assign them. So we're on the right path to dealing with the problem, but we're sauntering down it at a time when a sense of urgency is required.
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The second problem, of course, is that environmental research on nanotechnology is grossly underfunded. Conservative estimates of what's needed are more than twice as much as we're spending today. This is ''penny wise and pound foolish,'' to put it mildly, given what nanotechnology could contribute to our economy and what health problems from nanotechnology could detract from it.
So I hope that our discussion today can infuse everyone here—including the media and the public—with a sense of urgency about this problem. We need to come up with a mechanism in which priorities will be set for, assigned to, and actually carried out by the responsible federal agencies. Current coordinating mechanisms clearly are inadequate, and I hope we can have a good discussion today of what to do instead.
I know that diversity is a source of strength in our research establishment, and I am not one who believes that duplication is always a bad thing. But we have to bring some order to this process or we're going to squander our chance to understand nanotechnology on a schedule that will help business and protect the public.
So I look forward to hearing from our witnesses today, and I assure them we will be following up on this at the very least until the day I leave office on Dec. 31, and hopefully long past that.
Let me just address a couple of protocol matters before I turn to Mr. Gordon. First, I'm going to try to keep witnesses and Members to their five minutes because we have a large panel and votes may occur as early as 11:30. Second, let me say that normally, we would have Dr. Bement testify first as the highest ranking official on the panel, but we wanted to hear first from the official who is chairing the interagency effort to get some perspective. Finally, I understand that Mr. Farland has announced his retirement, and I want to thank him for his years of helping this committee and serving the public.
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Mr. Gordon.
Mr. GORDON. Thank you, Mr. Chairman.
As usual, I concur with your remarks, and let me assure you that that oversight will go beyond December 31 to honor you as well as to do our job here.
Let me recap.
This morning's hearing is a follow-up on our hearing of last November that addressed the health and environmental risks that may arise from applications of nanotechnology. That hearing clarified several important points and raised new issues. All the previous witnesses who represented government, industry, and non-government organizations stressed that nanotechnology will advance faster and receive public support if the environmental health and safety implications of the technology are understood.
To that end, all witnesses stressed the need for the interagency National Nanotechnology Initiative to include a prioritization and adequately funded component focused on environmental health and safety issues. The outside witnesses either recommended that NII—or rather NNI—increase funding for the EHS research or expressed frustration that they were unable to determine exactly what EHS research was being supported by NNI.
And finally, the Administration witness at the hearing told us an Interagency Working Group was developing a coordinated approach to nanotechnology research on EHS. This process would identify and prioritize research needs to assess the risks associated with engineering nanotechnology materials and be sufficiently detailed to guide researchers and research managers in making project-level decisions. That sounded like a good idea.
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We were told the research plan would be available by the spring of 2006, but it has only just appeared, as a matter of fact, last night, I think, at six o'clock. And unfortunately, it is not the prioritized research plan we expected to see. This is the product that came last night at six o'clock, although we were promised it this spring, and I am very disappointed—I think it is a very juvenile piece of work, given the time that you have had to work on this. You did not get the job done. And in the back of it, it says, ''Next steps.'' Well ''next steps'' seems to me like first steps. Next steps says ''further prioritize research needs among those identified in this report.'' Well, this report is just an accumulation of things that need to be done. There is no prioritization. That is what you were supposed to be doing in this one: evaluate in greater detail the current NNI EHS research portfolios. You don't know what those portfolios are yet? I mean, what have you been doing since 2003? I mean, it seems to me there is just a lack of urgency. Materials are out on the market now. You know, it is just really hard to understand.
Mr. Chairman, I, frankly, do not understand the inability of the responsible agencies to produce their research plan with well defined priorities and resources requirements. It is the first step for developing proposed research programs in associated budgets for fiscal year 2008. It is now late in the budget planning cycle for fiscal year 2008. So what then will the agencies use to guide their selection of EHS research projects and determine their budget requirements?
In the absence of a prioritized EHS research plan, I see no way to initiate a carefully crafted set of research programs that are relevant to the needs of the companies that will be developing and using nanomaterials and to the needs of the agencies charged with oversight of EHS aspects of nanotechnology.
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As we learned from the previous hearings, applications of nanomaterials are rapidly advancing. Consumer products employing nanomaterials are already on the market. The Wilson Center's Nanotechnology Project has identified at least 200 such products, many of which are actually designed to be ingested. Prudence suggests the need for urgency in having the science of health and environmental implications catch up to, or, even better, surpass the pace of commercialization.
But here we are today, nearly a year after our initial nanotechnology hearing on health and environmental risks, with little sign of forward progress in focusing the interagency research effort. I want to hear from our witnesses why progress has been so slow. Or if you are satisfied with this process and you think it is hunky-dory and we are just where we should be, I would like for you to tell us that. But if you are not satisfied, I would like for you to tell us why, and what we need to do from now.
We need to consider whether the interagency process under the NNI can be made to function to meet environmental health and safety needs. And if not, we must look for an alternative approach without further delay.
So, Mr. Chairman, this is a very important hearing, and I thank you for bringing us together for this.
[The prepared statement of Mr. Gordon follows:]
PREPARED STATEMENT OF REPRESENTATIVE BART GORDON
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This morning's hearing is a follow-on to our hearing of last November that addressed the health and environmental risks that may arise from applications of nanotechnology. That hearing clarified several important points and raised new issues.
All the previous witnesses, who represented government, industry, and non-government organizations, stressed that nanotechnology will advance faster and receive public support if the environmental, health, and safety implications of the technology are understood.
To that end, all witnesses stressed the need for the interagency National Nanotechnology Initiative (NNI) to include a prioritized and adequately funded component focused on environmental, health, and safety issues.
The outside witnesses either recommended that the NNI increase funding for EHS research or expressed frustration that they were unable to determine exactly what EHS research was being supported by the NNI.
And finally, the Administration witness at the hearing told us an interagency working group was developing a coordinated approach to nanotechnology research on EHS. This process would identify and prioritize research needs to assess the risks associated with engineered nanomaterials and be sufficiently detailed to guide researchers and research managers in making project-level decisions.
We were told the research plan would be available by the spring of 2006, but it has only just appeared. And, unfortunately it is not the prioritized research plan we expected to see.
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Mr. Chairman, I frankly do not understand the inability of the responsible agencies to produce a research plan with well defined priorities and resource requirements. It is the first step for developing proposed research programs and associated budgets for FY 2008.
It is now late in the budget planning cycle for FY 2008. What then will the agencies use to guide their selection of EHS research projects and to determine their budget requirements? In the absence of a prioritized EHS research plan, I see no way to initiate a carefully crafted set of research programs that are relevant to the needs of the companies that will be developing and using nanomaterials and to the needs of the agencies charged with oversight of EHS aspects of nanotechnology.
As we learned from the previous hearing, applications of nanomaterials are rapidly advancing. Consumer products employing nanomaterials are now on the market. The Wilson Center's Nanotechnology Project has identified at least 200 such products, many of which are actually designed to be ingested.
Prudence suggests the need for urgency in having the science of health and environmental implications catch up to, or even better surpass, the pace of commercialization. But here we are today, nearly a year after our initial nanotechnology hearing on health and environmental risks with little sign of forward progress in focusing the interagency research effort. I want to hear from our witnesses why progress has been so slow.
We need to consider whether the interagency process under the NNI can be made to function to meet environmental, health and safety needs. And if not, we must look for an alternative approach without further delay.
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Mr. Chairman, I believe that is the key issue the Committee should address relative to EHS research, and I look forward to the discussion today.
Chairman BOEHLERT. And I thank you for your opening statement.
Some of the sentiments you have expressed I share. I am not sure I—maybe it depends upon where you sit on how you would express it, but at least we are started, and we have got to get going. We have got to accelerate the pace. We have got to do a better job. I am not happy. You are not happy. And we have had good conversation, as is usual on this committee. This is a committee where we operate, I think, the way Congress should operate, and a lot of other committees. Guess what? We actually talk to each other. He has got a ''D'' after his name. I have got an ''R'' after my name. We know what is going to happen on November 7. It is going to be a big election. But we don't concentrate on politics. We concentrate on policy. And we are here collectively on this committee to try to encourage the best possible policy for the Nation, and we want to encourage all those present to work with us to accelerate the pace and do something quicker, better.
[The prepared statement of Mr. Costello follows:]
PREPARED STATEMENT OF REPRESENTATIVE JERRY F. COSTELLO
Good morning. I want to thank the witnesses for appearing before our committee to examine current concerns about environmental and safety impacts of nanotechnology and the status and adequacy of related research programs and plans.
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Relatively little is understood about the environmental and safety implications of nanotechnology. The lack of knowledge about the effects of nanoparticles and the absence of established methods to assess their impacts on the environment and human health is troubling since nanomaterials are already on the market in cosmetics, clothing and other products. Further, there are no established scientific protocols for either safety or environmental compatibility testing for nanomaterials.
I am pleased we are having this hearing today because greater knowledge is needed to enable a nanotechnology industry to develop and to protect the public. Regulation for certain types or applications of nanomaterials could eventually be needed and Congress needs more information on the environmental and safety impacts of nanotechnology to better protect the public.
I look forward to hearing from the panel of witnesses.
[The prepared statement of Mr. Lipinski follows:]
PREPARED STATEMENT OF REPRESENTATIVE DANIEL LIPINSKI
Thank you, Mr. Chairman. I am pleased to be here today for this hearing on nanotechnology. Nanotechnology is one of the most promising technologies of our time and could revolutionize industries ranging from transportation to medicine, as well as have a huge impact on improving our national security.
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Many universities and businesses are becoming invested in nanotechnology efforts in my home state of Illinois, which is one of the strongest states in nanotechnology research according to the Small Times Magazine. For example, Northwestern University, my alma mater, houses the Institute for Nanotechnology, which supports efforts in nanotechnology and facilitates collaboration in solving major problems in the field of nanotechnology. It includes the Center for Nanofabrication and Molecular Self-Assembly, a multi-million dollar research facility and one of the first federally funded centers of its kind. The Institute helps foster partnership to encourage researchers and entrepreneurs to become involved in this cutting edge technology, creating jobs and the potential for entirely new industries. In these times of increasing economic competitiveness, this new technology is extremely critical.
I would also like to recognize Jack Lavin, Director of the Illinois Department of Commerce and Economic Opportunity, for the work that he and the DCEO have done to make nanotechnology a strong presence in Illinois. They have worked to attract federal and private funds to the state to encourage the expansion of nanotechnology research and development and fully realize the vast economic benefits that our state will receive from current investment.
Yet there are numerous challenges still facing the development of nanotechnology, particularly regarding environmental and health safety. There is simply so much that we do not know about the ways that nanoparticles behave and how they interact with each other and other particles. The properties and behaviors can change dramatically when substances are reduced to such a small size. We need to at least better understand these changes. And this need is even more pressing considering that nanotechnology is already on the market in many products, from sun screen to stain resistant pants.
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The Federal Government must promote research and education about the impacts of these emerging technologies, both to ensure that negative effects are minimized and to facilitate public acceptance of nanotechnology. Development of nanotechnology is surging ahead, with America as a leader in the international community, and I am pleased to see that. But we must make sure that proper health and environmental safeguards are in place, and government regulation may be necessary to ensure this safety.
On this note, I am disappointed with the just-released prioritized environmental, health, and safety research plan from the National Nanotechnology Initiative, six months late and lacking a clearly prioritized set of research objectives with specific agency responsibilities and costs. I look forward to receiving more information from the Administration on the ''next steps'' listed in this plan.
There is so much potential for our economy with nanotechnology that we must find a safe and comprehensive way to resolve these issues. Our economic future may depend on it.
Thank you, Mr. Chairman.
Chairman BOEHLERT. With that, let me introduce this panel.
Dr. Norris Alderson, Chair of Nanotechnology, Environmental Health Implications Working Group, Associate Commissioner for Science for Food and Drug Administration.
Dr. Arden Bement, Director, National Science Foundation.
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Dr. William Farland, Deputy Assistant Administrator for Science, Office of Research and Development, U.S. Environmental Protection Agency. Thank you for your good work and your distinguished career.
Dr. Altaf Carim, Program Manager, Nanoscale Science and Electron Scattering Center, U.S. Department of Energy. Doctor.
Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars. Dr. Maynard.
And Mr. Matthew Nordan, President, Director of Research, Lux Research, Inc. Mr. Nordan, thank you very much.
And thank all of you for being resources for this committee, for helping provide a tutorial for us, because you know a hell of a lot more about this than we do. We are trying to learn, but we want to work together, and I always appreciate it and I am very gratified when I look down at the list of witnesses and see people of your caliber, your experience, your commitment.
So with that, let us go.
Dr. Alderson, you are first up.
STATEMENT OF DR. NORRIS E. ALDERSON, CHAIR, NANOTECHNOLOGY, ENVIRONMENTAL, AND HEALTH IMPLICATIONS WORKING GROUP; ASSOCIATE COMMISSIONER FOR SCIENCE, FOOD AND DRUG ADMINISTRATION
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Dr. ALDERSON. Good morning, Mr. Chairman, and Members of the Committee. Thank you for the opportunity to speak with you today about nanotechnology programs and the work of the Nanotechnology Environmental and Health Implications Working Group, or the NEHI Working Group.
I am Dr. Norris Alderson, Associate Commissioner for Science, at the Food and Drug Administration. As FDA's Associate Commissioner for Science, I am responsible for the management of the Office of Women's Health, the Office of Orphan Products Development and the Good Clinical Practices Staff. I am also responsible for coordination of science issues across the Agency, the oversight of FDA-sponsored clinical trials and standards coordination.
In addition to serving as Associate Commissioner for Science at FDA, I am also chair of the NEHI Working Group.
I have been with the NEHI Working Group since it was established by the Nanoscale Science, Engineering, and Technology, NSET, Subcommittee in 2003.
The purpose of the NEHI Working Group is to provide for the exchange of information among agencies that support nanotechnology research and those responsible for regulation and guidelines related to nanoproducts, products that contain engineered nanoscale materials to facilitate the identification, prioritization, and implementation of research and other activities required for the responsible research and development, utilization, and oversight of nanotechnology, including our research methods of life cycle analysis, and promote communication of information related to research on environmental and health implications of nanotechnology to other government agencies and non-government organizations.
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One of the key objectives of the NEHI Working Group is to exchange information on the issues raised within the participating regulatory agencies by advances in nanotechnology. The NEHI Working Group assists in the development of information and strategies as a basis for the drafting by the regulatory agencies of guidance toward safe handling and use of nanoproducts by researchers, workers, and consumers. Further, the group is working to support development of nanotechnology standards, including nomenclature and terminology, by consensus-based standards organizations.
In pursuit of these aforementioned objectives, activities of the NEHI Working Group over the past two years include, and I just want to mention a few because of the time:
First, communication by participating regulatory agencies concerning their respective statutory authorities for regulating nanoproducts, and their approaches for carrying out these authorities. We encouraged all of the participating regulatory agencies to develop a position statement of how they are addressing nanotechnology. This resulted in all of the agencies developing a website on their positions. We developed a preliminary ''risk assessment influence diagram'' that was ultimately published as a peer-reviewed publication. We have had discussions with various relevant standards bodies regarding nomenclature and terminology. And we have compiled the inputs from participating agencies on their perceived needs for EHS research and information and development of a draft document drawn from this compilation and inputs from industry. This draft document is now a final document, and it is a product of these activities that is in a report entitled ''Environmental Health and Safety Research Needs for Engineered Nanoscale Materials.'' I have the report, Mr. Chairman, and would like to submit a copy for the record. (See Appendix 2: Additional Materials for the Record.)
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Chairman BOEHLERT. Without objection, so ordered.
Dr. ALDERSON. The primary purpose of this document is to identify for the Federal Government the EHS research and information needs related to understanding and management of potential risks of engineered nanoscale materials that may be used in commercial or consumer products, medical treatments, environmental applications, research, or elsewhere. In addition, industry producers and users of engineered nanoscale materials may use this document to inform their own research, risk assessment, and risk management activities.
The report is the first step in addressing the research needed to support informed risk assessment and risk management of nanomaterials. The document represents over a year of intensive work by the participating agencies.
In addition to gathering input from its members for the purposes of this report, the NEHI Working Group has considered a number of public documents, and those are included in the report. These are both domestic and international documents. These ideas were then grouped into five categories, which you will see in the report.
Research on nanoscale materials is supported by each agency respectively, based on its primary scientific mission. For example, the NIH supports a broad spectrum of biological nanoscale research ranging from basic science to clinical and translational investigations and clinical trials. The National Science Foundation supports basic research on engineered nanoscale materials and cells.
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Chairman BOEHLERT. Excuse me, Mr. Alderson, could you somewhat wrap up? We are going to try to stick to the—here is what——
Dr. ALDERSON. Right.
Chairman BOEHLERT.—we are going to do. We are going to try to stick to the five minutes for everybody else. We are giving you a little leeway, because you are the Chair of the panel. But from my experience, I know when Administration witnesses come up, they tell us what they are doing right. We understand what you are doing right, but there are a lot of things that we are not happy with. And we know what the charge is, but we are not pleased with the implementation plan. So if you could, wrap it up, and then we could get to the other witnesses. And I am going to try to keep the other witnesses to the five minutes so we really can engage.
Dr. ALDERSON. Will do.
Chairman BOEHLERT. Thank you, sir.
Dr. ALDERSON. With the completion of the report released today, issues that remain to be addressed in the future include a step-wise process of determining priorities. Under the guidance of NSET, I expect the NEHI Working Group to play an active role in all of the ''next steps'' mentioned above, although the Working Group will serve only in an advisory capacity with respect to assisting agencies in setting their respective research priorities.
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Thank you again for the opportunity to testify, Mr. Chairman. I appreciate the Committee's continued interest in nanotechnology, and I would be happy to answer any questions you may have.
[The prepared statement of Dr. Alderson follows:]
PREPARED STATEMENT OF NORRIS E. ALDERSON
INTRODUCTION
Mr. Chairman and Members of the Committee, thank you for the opportunity to speak with you today about nanotechnology programs and the work of the Nanotechnology Environmental and Health Implications (NEHI) Working Group. I am Dr. Norris Alderson, Associate Commissioner for Science, at the Food and Drug Administration (FDA or the Agency). As FDA's Associate Commissioner for Science, I am responsible for the management of the Office of Women's Health, the Office of Orphan Products Development, the Good Clinical Practices Staff, coordination of science issues across the Agency, and oversight of FDA-sponsored clinical studies and standards coordination.
OVERVIEW
Nanotechnology is expected to contribute to scientific advances in medicine, energy, electronics, materials, and other areas. Many of the benefits of nanotechnology arise from the fact that nanomaterials exhibit properties and behavior different from those of materials at larger scales. These unique properties that enable new benefits, however, also could lead to nanomaterial-specific human health and environmental risks.
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That a new technology could offer both benefits and, at the same time, potential risk, is not unique to nanotechnology. Other common examples are electricity, household cleaning supplies, gasoline, and medical X-rays. Learning more about risks of technologies provides information for their successful management and the realization of their benefits.
NANOTECHNOLOGY ENVIRONMENTAL AND HEALTH IMPLICATIONS (NEHI) WORKING GROUP
I have been involved in the Nanotechnology Environmental and Health Implications (NEHI) Working Group since its inception. The Nanoscale Science, Engineering, and Technology (NSET) Subcommittee established the Working Group informally in late 2003 and formally chartered it in 2005.
The purpose of the NEHI Working Group is to provide for exchange of information among agencies that support nanotechnology research and those responsible for regulation and guidelines related to nanoproducts (containing engineered nanoscale materials); facilitate the identification, prioritization, and implementation of research and other activities required for the responsible research and development, utilization, and oversight of nanotechnology, including research methods of life-cycle analysis; and promote communication of information related to research on environmental and health implications of nanotechnology to other government agencies and non-government organizations.
One of the key objectives of the NEHI Working Group is to exchange information on the issues raised within the participating regulatory agencies by advances in nanotechnology. The NEHI Working Group assists in the development of information and strategies as a basis for the drafting by the regulatory agencies of guidance toward safe handling and use of nanoproducts by researchers, workers, and consumers. Further, the group is working to support development of nanotechnology standards, including nomenclature and terminology, by consensus-based standards organizations.
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In pursuit of these aforementioned objectives, activities of the NEHI Working Group over the past two years include:
communication by participating regulatory agencies concerning their respective statutory authorities for regulating nanoproducts, and their approaches for carrying out those authorities;
encouraging all the participating regulatory agencies to develop a position statement on how they are addressing nanotechnology (an effort that has resulted in the establishment of a nanotechnology web site at most of the participating regulatory agencies);
development of a preliminary ''risk assessment influence diagram'' to help guide the NEHI Working Group's approach to thinking about potential risks from nanoproducts and services (this effort led to a peer-reviewed scientific publication);
discussion with various relevant standards bodies regarding nomenclature and standards development for nanotechnology that will affect both regulators and researchers; and
compiling the inputs from participating agencies on their perceived needs for Environmental, Health, and Safety (EHS) research and information and development of a draft document drawn from this compilation and inputs from industry and other similar documents from other countries and organizations.
A product of these activities is a report titled Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials.
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THE NEHI WORKING GROUP REPORT
The primary purpose of this document is to identify for the Federal Government the EHS research and information needs related to understanding and management of potential risks of engineered nanoscale materials that may be used in commercial or consumer products, medical treatments, environmental applications, research, or elsewhere. In addition, industry producers and users of engineered nanoscale materials may use this document to inform their own research, risk assessment, and risk management activities.
The report is the first step in addressing the research needed to support informed risk assessment and risk management of nanomaterials. The document represents over a year of intensive work by the participating agencies.
In addition to gathering input from its members for the purposes of this report, the NEHI Working Group has considered a number of public documents on the subject of EHS research while drafting this report. Included were documents from the chemical industry, the Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), the Royal Society/Royal Academy of Engineering in the United Kingdom, and the Scientific Committee on Emerging and New Identified Health Risks/European Commission.
Once the research needs were identified, they were grouped into five areas:
1. Instrumentation, metrology, and analytical methods
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2. Nanomaterials and human health
3. Nanomaterials and the environment
4. Health and environmental surveillance
5. Risk management methods
Research on nanoscale materials is supported by each agency, respectively, based on its primary scientific mission. The National Institutes of Health (NIH) supports a broad spectrum of biological nanoscale research ranging from basic science to clinical and translational investigations and clinical trials; the National Science Foundation (NSF) supports basic research on interactions between engineered nanoscale materials and cells. The EPA looks at broader implications for both human health and the environment including how nanomaterials will potentially affect whole ecosystems containing many different organisms. In some cases, such as the EPA–NSF–NIOSH–National Institute of Environmental Health Sciences joint interagency solicitation on environmental implications of nanotechnology, agencies conduct joint review of proposals, and then allocate the top rated proposals among themselves according to their respective missions and program emphases.
The NEHI Working Group Report supports NSET's mandate to coordinate federal nanoscale research activities. The document will serve as a uniform guide for all federal agencies in developing their plans to support environmental, health, and safety research on the implications of nanoscale materials.
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NEXT STEPS
With the completion of the report released today, issues that remain to be addressed in the future include:
Further prioritize research needs. Priorities will be evaluated based primarily on the principles outlined in the document. Other factors that will be considered include the time frame for developing the information—because certain studies are inherently lengthy—and the availability of research tools.
Evaluate in greater detail the current National Nanotechnology Initiative (NNI) EHS research portfolio.
Perform a ''gap analysis'' of the NNI EHS research compared to the prioritized needs.
Coordinate and facilitate among the NNI agencies research programs to address priorities. Agencies will work individually and jointly, where possible, to address research needs.
Establish a process for periodically reviewing progress and for updating the research needs and priorities. Such a review must take into consideration advances made by entities other than U.S. Government-funded bodies, such as advances by the private sector and foreign governments.
CONCLUSION
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I expect the NEHI Working Group to play an active role in all of the ''next steps'' mentioned above; although, the Working Group will serve only in an advisory capacity with respect to assisting agencies in setting their respective research priorities. Thank you again for the opportunity to testify today, Mr. Chairman. I appreciate the Committee's continued interest in nanotechnology, and I am happy to answer any questions you may have.
BIOGRAPHY FOR NORRIS E. ALDERSON
Associate Commissioner for Science, U.S. Food and Drug Administration (FDA). Dr. Alderson began his career in FDA in 1971 following a BS degree from the University of Tennessee and MS and Ph.D. degrees and post-doctoral work at the University of Kentucky. The majority of his FDA career has been in the Center for Veterinary Medicine, holding a number of management positions, culminating in the position of Director, Office of Research. In 2001, he became Acting Senior Advisor for Science, and Acting Director, Office of Science Coordination and Communication. In 2002, he was appointed Senior Associate Commissioner for Science, and Director, Office of Science and Health Coordination. The title was later changed to Associate Commissioner for Science. In his current position, he is responsible for coordination of science issues across the agency, the Office of Women's Health, Office of Orphan Products Development, the Good Clinical Practices Staff, oversight of FDA sponsored clinical studies, and standards coordination.
Chairman BOEHLERT. Thanks very much. And incidentally, this committee has been privileged to have—to be familiar with all of you, because you have been before us. So—and I can say this without any fear of contradiction, that we know you individually and your careers, and we have high regard for you. And—but we are frustrated. I know how difficult it is to get interagency panels to act, and I know every single one of you have very demanding schedules. And this isn't the only item on your agenda. But I hope you take from this hearing the feeling that both of us, all of us on this committee, would like it to be a little bit higher on your respective agendas, a little bit higher priority so that we can get beyond the preliminary stages. And I am being kind when I say, ''Well, this is an important first step,'' but we should be a couple of steps ahead.
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Dr. Bement.
STATEMENT OF DR. ARDEN L. BEMENT, JR., DIRECTOR, NATIONAL SCIENCE FOUNDATION
Dr. BEMENT. Chairman Boehlert, Ranking Member Gordon, and distinguished Members of the Committee, I am pleased to be with you once again to speak on behalf of the National Science Foundation.
However, before I begin my formal remarks today, Mr. Chairman, I want to extend a very warm personal note of appreciation for your support of NSF. Throughout the years, your leadership has been of immeasurable value to the science and engineering community. I know the work that you have done here will continue to strengthen this nation for years to come.
Chairman BOEHLERT. Thank you very much, sir.
Dr. BEMENT. Nowhere is that impact more evident than in the emerging field of nanotechnology. The amazing advances we have seen in this new frontier are, in no small part, due to your leadership in Congress on this issue. Your tremendous help in pushing the Administration's American Competitiveness Initiative will provide even more opportunities for discovery.
Mr. Chairman, with your help, NSF not only provides leadership for the National Nanotechnology Initiative, we also provide the lion's share, 72 percent, of the NNI's $82 million research investments into the societal dimensions of nanotechnology. NSF also provides nearly 60 percent of the total NNI Environmental Health and Safety funding. These investments are critical, because we cannot effectively and safely exploit nanotechnology's fast potential without also understanding its societal implications.
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NSF research in this area is categorized into three main groups: environmental health and safety; education; and ethical, legal, and social issues.
Of our investment, nearly half goes to fundamental research on the environmental health and safety aspects of nanomaterials. This also includes studying risk assessment. This research covers all the possible sources of nanoparticles: those created through manufacturing, those produced as a byproduct of other processes, and those existing naturally in the environment.
NSF research also investigates how nanoparticles behave in a variety of settings: in the laboratory, in water, in the air, and in the workplace. We also study their non-clinical biological implications, such as the development of new instrumentation to measure toxicity.
Funding a research agenda for these important areas is challenging, but managed in a variety of coordinated activities. NSF contributes and coordinates its NNI research and education activities through the Nanoscale Science, Engineering, and Technology Subcommittee, or NSET, of the National Science and Technology Council. Our activities are well integrated in the NSTC through periodic meetings, strategic and annual planning processes, co-sponsoring and co-funding events of program solicitations, all in the framework of NSET and the National Nanotechnology Coordination Office.
NSF is also part of NSET's subcommittees, namely Nanotechnology Environmental and Health Implications Working Group, or NEHI. This group provides regular interactions with other agencies that support research in regulatory activities.
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In the recent past, we have coordinated grantees meetings with the Environmental Protection Agency, the National Institute of Environmental and Health Sciences, the National Institute for Occupational Safety and Health, and other agencies. These meetings help ensure open lines of communication, cross-fertilization of ideas, funding of complementary projects, and leveraging.
NSF also sets internal annual priorities for its nanoscale science and engineering research. Input for these priorities come from the NSF's Nanoscale Science and Engineering Working Group, the NNI Strategic Plan, the National Academies, other national, international, and industry perspectives as well as from grass roots sources, such as the general public and your grantees meetings, and other non-governmental sources.
The NSF, according to its mission, conducts fundamental environmental health and safety research. This fundamental research complements the more directed approach of regulatory agencies in improving our understanding of the behavior of nanoparticles in the environment and their implications for human health and the ecology.
NSF's fundamental research also complements the toxicity studies conducted by the National Institutes of Health and regulatory activities of the EPA, the Food and Drug Administration, and NIOSH.
Mr. Chairman, NSF works closely with the regulatory agencies by offering our unique expertise and strength in fundamental research. This research will add to the overall body of knowledge on nanotechnology, provide the future workforce, and will prove essential to the regulatory mission agencies' abilities to develop science-based standards.
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Mr. Chairman, I hope that this brief overview conveys to you NSF's continued commitment to advance science and technology in the national interest. I appreciate you and your Committee's longstanding support of NSF, and I will be pleased to answer any questions you may have.
[The prepared statement of Dr. Bement follows:]
PREPARED STATEMENT OF ARDEN L. BEMENT, JR.
Fundamental Nanotechnology Research: The Key to Finding the Promise and Minimizing the Peril
Chairman Boehlert, Ranking Member Gordon, and distinguished Members of the Committee, I am delighted to be with you once again to speak on behalf of the National Science Foundation. NSF is an extraordinary agency, with an equally extraordinary mission of enabling discovery, supporting education, and driving innovation—all in service to society and the Nation.
The past several months have been particularly exciting for the NSF and the U.S. research community. As you are well aware, the National Science Foundation is an integral part of the President's American Competitiveness Initiative (ACI). The President's request for an eight percent increase at NSF this year represents the first step in the Administration's commitment to doubling the budgets of the ACI research agencies over the next 10 years.
The ACI encompasses investments across NSF's research and education portfolio. NSF's investments in discovery, learning, and innovation have a longstanding and proven track record of boosting the Nation's economic vitality and competitive strength. This level of commitment is recognition of the urgent and ongoing need to invest in our nation's future through fundamental research and innovation.
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Frontier research is NSF's unique task in pursuing the Administration's research priorities within the larger federal research and development effort. Over the years, NSF has advanced the frontier with support for pioneering research that has spawned new concepts and even new disciplines. NSF provides strong support in fundamental research for activities coordinated by the National Science and Technology Council (NSTC), including our role as a lead federal agency in the multi-agency National Nanotechnology Initiative (NNI).
But before I begin, let me thank this committee for its historic and ongoing support of NSF. I also want to extend special thanks—on behalf of everyone associated with the National Science Foundation—to Representative Boehlert for his many years of leadership as Chairman of the House Science Committee. The science and engineering community appreciates all that you have done as a champion for our nation's quest for knowledge.
Nanotechnology—First Steps and Demand for Fundamental Principles
Ten years ago, predicting the state of nanotechnology research today would have been a fruitless gesture. In the 1990s, NSF and other research entities around the globe were just beginning to apply nanoscale concepts to the frontiers of science and engineering.
Though some visionary researchers certainly recognized the vast potential of skillful atomic and molecular manipulation, no one could have predicted the enormous impact of these early steps into a new realm of discovery. One reason for this lack of prescience is our limited understanding of the physical principles that come into play on the nanoscale.
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The research community's first vision for nanotechnology was based on our understanding of the macro world, where the same laws and physical properties of our everyday experience hold sway, regardless of size or scale. We now know that this simplistic view was woefully inaccurate. The world of nanotechnology—it turns out—is an often topsy-turvy world where familiar physical properties disappear and new capabilities emerge.
Consider something with which we are all familiar—ordinary gold. Whether in a ring, shielding sensitive electronics in space, or kept as a trusted investment for a rainy day, gold behaves in the same predictable ways. It has a certain color, luster, hardness, and melting point. This is true for an ounce or a metric ton. But something remarkable happens when we study the vanishingly small bits of gold called nanodots. On the nanoscale, gold no longer behaves the same as it does in our day-to-day lives. Its color changes to a striking red (as ancient stained-glass artists learned), and it's no longer the inert metal used in home and biological appliances. Rather, under certain circumstances, gold nanoparticles may be very reactive, may penetrate the blood/brain barrier, or may enter into cells.
So we have to ask ourselves: as the NSF funds fundamental nanoscale research, how should we address the societal issues associated with the development and use of nanotechnology, and in particular engineered nanoscale materials.
Societal Dimensions
We typically refer to the impact of nanotechnology on the environment, humans, cultures, and societal relationships as the ''societal dimensions'' of nanotechnology. NSF characterizes research in this area into three main groups:
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Environment, Health, and Safety
Education, and
Ethical, Legal, and other Social Issues.
Each pillar of this triumvirate is indispensable, and removing one would weaken the stability of our efforts to effectively and safely exploit nanotechnology's vast potential, which is why NSF's support of fundamental research is so critical. Of the total 2007 NSF Request within the National Nanotechnology Initiative of $373.2 million, $59 million—or 16 percent—is directed toward societal dimensions.(see footnote 27) This is a $7.5 million (15 percent) increase over the FY 2006 estimated funding of $51.5 million.
* FY 2001–2004 data retrospectively collected based upon FY 2005 OMB guidance.
29852e.eps
Because of NSF's critical impact on building a fundamental body of knowledge, specialized facilities, and qualified people, NSF funds a large fraction of the overall National Nanotechnology Initiative (NNI) investment in Societal Dimensions: $59 million of $82.1 million in the FY 2007 Request, and $51.5 million of $71.7 million in the FY 2006 estimate.
NSF dedicates about seven percent of its NNI budget to projects that focus primarily on fundamental aspects of environmental, health, and safety implications and applications of nanomaterials, and basic research that assesses the risk of these implications. This comes to $25.7 million or 6.9 percent of the total FY 2007 NNI/NSF Request, or $3.6 million over the FY 2006 estimate.
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Setting a Research Agenda
NSF sets annual priorities for nanoscale science and engineering research. Input for these priorities comes from the NSF's Nanoscale Science and Engineering Working Group; the NNI strategic plan; other national, international, and industry perspectives; as well as from grassroots sources such as the general public, annual grantees meetings, and other non-governmental sources.
Another important input in developing the NSF's NNI-related research and education activities is through participation in the Nanoscale Science, Engineering and Technology Subcommittee (NSET) of the National Science and Technology Council (NSTC) Committee on Technology. NSF participates in all NNI workshops, research directions and planning meetings, and is coordinating its programs with the work done by other agencies in the general context of R&D, infrastructure, and education needs. NSF is also part of the NSET Subcommittee's Nanotechnology Environmental and Health Implications Working Group (NEHI), through which it has systematic interactions with other agencies supporting research and regulatory activities. NSF also has co-organized grantees meetings with the Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and other agencies to ensure open lines of communication, cross-fertilization of ideas, funding of complementary projects, and leveraging. Since FY 2001, the results from these meetings, and nanoscale science and engineering awards and solicitations, have been placed on NSF's dedicated nanotechnology web site: www.nsf.gov/nano.
NSF also receives input from industry on the impact of this research agenda, ensuring that it is both deep and broad, and one that will serve the fundamental research needs of the entire community.
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NSF Focus on Environmental, Health, and Safety Research
As stated earlier, NSF—through its proven system of merit review—seeks to advance the central body of knowledge on nanotechnology and corresponding infrastructure by support for fundamental research, not including clinical testing, and other activities that address broad societal dimensions. We do not fund product development or late-stage innovation: the research necessary to move a product into a commercial market.
NSF research addresses a variety of nanoparticles and nanostructured materials in different environmental settings (air, water, soil, biosystems, and working environment), as well as the non-clinical biological implications. These topics are supported through programs in all the NSF research directorates.
There are several priority areas for environmental, health, and safety research at NSF. These key EHS priority research areas are:
new measurement methods and instrumentation for nanoparticle characterization and nanotoxicity,
transport phenomena of nanoscale aerosols and colloids, interaction of nanomaterials with cells and living tissues,
safety in nanomanufacturing, physico-chemical-biological processes of nanostructures dispersed in the environment,
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separation of nanoparticles from fluids,
development of user facilities, and
educational programs supporting EHS issues.
For example, the NSF is funding research on the safety of manufacturing nanoparticles through four Nanoscale Science and Engineering Centers (NSECs) and one Network:
The NSEC at Rice University in Houston is investigating the evolution of manufacturing nanoparticles in the wet environment;
The NSEC at Northeastern University in Boston is looking into occupational safety during nanomanufacturing;
The University of Pennsylvania's NSEC is exploring the complex behavior and interactions between nanomaterials and cells; and,
The NSEC at University of Wisconsin, Madison, is looking broadly at the effects of nanostructured polymers on Environmental Health and Safety.
The National Nanotechnology Infrastructure Network is also exploring societal dimensions through nanoparticle characterization centers at the University of Minnesota and Arizona State University.
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Additionally, about twenty interdisciplinary research teams (NIRTs) were funded in the EHS area since FY 2001.(see footnote 28) Research through these teams has covered such diverse topics as:
Theoretical and experimental methods of describing the formation and transformation of carbon nanoparticles in the atmosphere.
The effect on human cells of exposure to single-wall carbon nanotubes. Research at the Houston Advanced Research Center has indicated that these nanotubes have less toxicity than carbon black and silica. However, research results on toxicity depend on many factors and more knowledge is needed before a final conclusion can be reached.
NSF also is looking into the robust large-scale manufacturing of nanoparticles and their toxicology. This project will involve an academic-government-industrial partnership, encompassing chemistry, chemical and mechanical engineering, and medicine. Extensive tests will be performed on toxicology. Mechanisms of particle/cell interactions will also be evaluated, and the potential adverse and beneficial effects will be determined.
An NSF-supported Nanoscale Interdisciplinary Research team is investigating ceramic membranes for filtration of nanoparticles, which is relevant in control technology for manufacturing processes involving aqueous nanoparticles.
An NSF-supported Nanoscale Interdisciplinary Research team is developing solvent-free techniques, using supercritical carbon dioxide, for the de-agglomeration of nanoparticles. This will enable environmentally benign manufacturing of high-surface-area nanostructured composites.
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In addition to the Center and NIRT awards, single investigator and small group awards provides creative ideas and innovation across all directorates in NSF. Several examples are:
Several NSF awardees are developing instrumentation for monitoring nanoparticles which could be useful for ensuring the proper operation of control technology in factories. Examples include instrumentation for:
— in-situ, real-time, high-resolution measurements of nanoparticle size distributions
— chemical composition of nanoscale aerosols
— size-resolved measurements of surface tension, critical supersaturation, and chemical composition of nanoscale cloud condensation nuclei, which will help elucidate the role of organic materials in environment
Laser Doppler Velocimetry (LDV) in synchronous AC electric and acoustic fields, to determine the size and charge of nanoparticles. These technologies could also be used to monitor nanoparticle emissions in the environment, providing critical information for the design and implementation of mitigation strategies where needed.
An NSF Nanoscale Exploratory Research project is developing risk scenarios for the full life-cycles of three types of nanoparticles currently manufactured in multi-ton quantities: endohedral metallo-fullerenes, titania nanoparticles, and carbon nanotubes. The project's broad interdisciplinary approach, including toxicity studies, life-cycle analysis, hierarchical holographic modeling, and assessment of the existing regulatory framework, will serve as a model for to identifying environmental impacts and risks of nanomaterials.
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Since FY 2002, NSF has had a Nanotechnology Undergraduate Education program. The program is currently sponsoring an effort to introduce research-based environmental nanotechnology experiences into the undergraduate curricula. Research-based hands-on laboratory modules will introduce students to the effects of nanomaterials on the environment and the potential use of nanomaterials for removal of environmental pollutants.
We also support fundamental research on decision making, risk, and uncertainty as part of our Human and Social Dynamics portfolio. This research will yield insight into decision-making processes, loss and mitigation models, and risk perception that are widely applicable to managing the risks and general governance associated with emerging technologies including nanotechnology.
NSF has also released a number of solicitations that deal directly with the societal impacts of nanotechnology. These include an NSF-wide solicitation in FY 2001 to FY 2005 that had two major research and education themes: nanoscale processes in the environment, and societal implications of nanotechnology. There also was a solicitation in FY 2006 and FY 2007 on active nanostructures and nano-devices.
Research to Enable Risk Assessment and Risk Management
What sort of research is necessary to enable sound risk assessment and risk management of nanotechnology? And what is the role of NSF in supporting that research? NSF's unique expertise and strength of its human and administrative resources is in fundamental research. This research will add to the overall body of knowledge on nanotechnology, will prove essential to the regulatory mission agencies' abilities to develop science-based standards, and complements the more applied approach of EPA, toxicity studies by the National Institutes of Health, and regulatory activities by the Food and Drug Administration and NIOSH.
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By creating the strong foundation of fundamental research, NSF catalyses the development of trained researchers, the future workforce, and the laboratory infrastructure that is needed for the mission specific research and development in the regulatory agencies.
As with any new technology, the benefits and risks of nanotechnology need to be evaluated from the beginning; nanotechnology has been exemplary in this regard. But research to understand the benefits and risks cannot advance without the combination of fundamental research, domain specific research, and technology and product specific research. This is where a balanced approach ensures the best results. Without these three components, the successful long-term commercialization of new products is at risk.
This foundation for commercialization is of great concern to industry, and NSF activity integrates their input and concerns into its research agenda. NSF receives input from industry through the Collaborative Boards for Advancing Nanotechnology, which was established by NNI with the electronic industry, the chemical industry, and other businesses and organizations.
NSF, therefore, does have an important role to play in enabling the acceptance of nanotechnology-based goods in the marketplace. Primarily, this is through fundamental research and the development of the necessary infrastructure—education, physical infrastructure for nanomaterials research, and more comprehensive topics such as nomenclature, metrology, and patent-evaluation framework. NSF also develops the institutional capability for R&D, production, information dissemination, safe use and regulations, and commercialization of nanotechnology. Above all, NSF supports the long-term R&D for new generations of nanoproducts. NSF research is most effective when targeted at long-term results and broad impacts that cut across the entire research landscape.
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The Public and Nanotechnology
NSF supports a host of education-related activities to communicate the state and future direction of nanotechnology research. This includes developing materials for schools, curriculum development for nanoscience and engineering, development of new teaching tools, and K–12 and public outreach. Three networks for nanotechnology education and societal dimensions with national outreach have been established:
The Nanotechnology Center for Learning and Teaching, with the main node at the Northwestern University, will reach one million students in high school and undergraduate education in all 50 states in the next five years;
The Nanoscale Informal Science Education, focused at the Museum of Science in Boston will address innovative science learning approaches, supplement K–12 education, and engage adult audiences; and
The Network for Nanotechnology in Society will address both short-term and long-term societal implications of nanotechnology, as well as public engagement.
The success of these efforts, however, hinges on a firm foundation of research across all areas and considering all implications. That outcome can only be achieved with the fundamental, broad-based research supported by NSF.
Conclusion
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For many years, NSF has used the slogan ''Where Discoveries Begin'' to welcome people to our web site. That phrase, however, did not come from a focus group or a marketing guru: it came from our mission—our mission of research and discovery. The same is true for nanotechnology. NSF is where the discoveries begin.
Mr. Chairman, I hope that this brief overview conveys to you NSF's continued commitment to advance science and technology in the national interest. If there is one thing that I would want to leave you with is that the vital, critical, and highly visible regulatory decisions that will need to be made will be based on the equally vital, critical, yet—by and large—unseen fundamental research that is NSF's hallmark.
I appreciate your—and your committee's—longstanding support of NSF. I would be pleased to answer any questions that you may have.
Thank you.
BIOGRAPHY FOR ARDEN L. BEMENT, JR.
Arden L. Bement, Jr., became Director of the National Science Foundation on November 24, 2004. He had been Acting Director since February 22, 2004.
He joined NSF from the National Institute of Standards and Technology, where he had been director since Dec. 7, 2001. Prior to his appointment as NIST director, Bement served as the David A. Ross Distinguished Professor of Nuclear Engineering and head of the School of Nuclear Engineering at Purdue University. He has held appointments at Purdue University in the schools of Nuclear Engineering, Materials Engineering, and Electrical and Computer Engineering, as well as a courtesy appointment in the Krannert School of Management. He was director of the Midwest Superconductivity Consortium and the Consortium for the Intelligent Management of the Electrical Power Grid.
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Bement served as a member of the U.S. National Science Board from 1989 to 1995. The board guides NSF activities and also serves as a policy advisory body to the President and Congress. As NSF director, Bement will now serve as an ex officio member of the NSB.
He also chaired the Commission for Engineering and Technical Studies and the National Materials Advisory Board of the National Research Council; was a member of the Space Station Utilization Advisory Subcommittee and the Commercialization and Technology Advisory Committee for NASA; and consulted for the Department of Energy's Argonne National Laboratory and the Idaho National Engineering and Environmental Laboratory.
Bement joined the Purdue faculty in 1992 after a 39-year career in industry, government, and academia. These positions included: Vice President of Technical Resources and of Science and Technology for TRW Inc. (1980–1992); Deputy Under Secretary of Defense for Research and Engineering (1979–1980); Director, Office of Materials Science, DARPA (1976–1979); Professor of nuclear materials, MIT (1970–1976); Manager, Fuels and Materials Department and the Metallurgy Research Department, Battelle Northwest Laboratories (1965–1970); and Senior Research Associate, General Electric Co. (1954–1965).
He has been a director of Keithley Instruments Inc. and the Lord Corp. and was a member of the Science and Technology Advisory Committee for the Howmet Corp. (a division of ALCOA).
Bement holds an Engineer of Metallurgy degree from the Colorado School of Mines, a Master's degree in metallurgical engineering from the University of Idaho, a doctorate degree in metallurgical engineering from the University of Michigan, an honorary doctorate degree in engineering from Cleveland State University, and an honorary doctorate degree in science from Case Western Reserve University. He is a member of the U.S. National Academy of Engineering.
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Chairman BOEHLERT. Thank you very much, Dr. Bement.
You know, you are only 20 seconds over, but since you had that nice preamble, I allowed that.
Dr. Farland.
And incidentally, I apologize to no one. I am an unabashed cheerleader for the National Science Foundation. It does marvelous work.
Thank you.
STATEMENT OF DR. WILLIAM H. FARLAND, DEPUTY ASSISTANT ADMINISTRATOR FOR SCIENCE, OFFICE OF RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY
Dr. FARLAND. Thank you, Mr. Chairman and Members of the Committee, for the invitation to appear here today and provide testimony on behalf of the Environmental Protection Agency. Mr. Chairman, thank you for your kind words regarding my career.
I am Dr. William Farland, Deputy Assistant Administrator for Science for the Office of Research and Development. EPA has been and will continue to be a leader in promoting development of environmental applications. EPA understands the potential implications of nanotechnology and vigorously pursues collaborations with United States and international scientists and policy makers. My submitted testimony describes our research needs in this area and how EPA is going about meeting these needs.
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EPA recognizes that nanotechnology has the potential to improve the environment, both through direct applications to detect, prevent, and remove pollutants as well as through design of cleaner industrial processes and creation of environmentally-friendly products.
However, some of the same unique properties that make manufactured nanoparticles beneficial also raise questions about the impacts of nanoparticles on human health and the environment. The evaluation of potential nanoparticle toxicity is complex, possibly being regulated by a variety of physical chemical properties, such as size and shape, as well as surface properties, such as charge area reactivity, coating type, and others.
As products made from nanoparticles become more numerous, the potential for release of nano-sized particles into the environment may also increase. The EPA, under its various statutes, has an obligation to ensure that potential environmental risks are adequately understood and managed. Potential environmental risks are dealt with as we review information on nanomaterials to assess and understand these risks and take control measures, as needed. For example, EPA is reviewing pre-manufacture notifications on nanomaterials that have been received under Section 5 of the Toxic Substances Control Act. It is important that throughout our evaluation of nanotechnology, decision making be informed by the best available scientific information.
I mentioned that EPA has been a leader in research on the application and implications of nanotechnology in the environment. EPA began funding research on nanotechnology under its Science To Achieve Results, or STAR program, in 2001. Some 36 grants totaling nearly $12 million have been funded since that time to identify beneficial environmental applications, addressing prevention, sensors, treatment, and remediation.
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In addition, through its Small Business Innovation Research, or SBIR program, EPA has supported projects addressing nanotechnology applications. Beginning in 2003, EPA turned its focus to the potential environmental implications of nanotechnology and has now funded an additional 30 implications projects totaling approximately $10.4 million under the STAR program. This research is addressing exposure, fate and transport of nanomaterials in the environment, and potential human and environmental toxicity. We partnered with the National Science Foundation, National Institute of Environmental Health Sciences, NIOSH, and have funded additional projects under these solicitations with their help. Currently EPA and the three partner agencies are reviewing the proposals from the latest joint solicitation to make new funding decisions.
While some EPA research needs are shared by other federal agencies, EPA has particular needs to support its statutory mandates. To that end, EPA has set research priorities that reflect these program needs. EPA plans to issue the final version of its nanotechnology white paper in the near future. This paper was released in December of 2005 as the review draft that describes EPA nanotechnology research needs. The needed research is in the following broad areas: chemical identification and characterization, environmental fate, environmental detection and analysis, potential releases to the environment and human exposures, and human health effects, as well as ecological effects.
Based on the President's fiscal year 2000 budget request, $8.6 million will go toward nanotechnology research. The EPA is developing a nanotechnology research framework for fiscal years 2007 through 2012 that is problem-driven, focusing on addressing the agency's programmatic needs. EPA will conduct research to understand whether nanoparticles in particular, and those with the greatest potential to be released into the environment or trigger a hazard concern, pose significant risks to human health or ecosystems by looking at the life cycle of nanoparticles. We are also working with our federal partners to conduct research to identify approaches for detecting and measuring nanoparticles in the environment and looking at pollution prevention and enhancing manufacturing processes.
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Based on these kinds of recommendations, we will be able to continue our collaborative efforts in these research areas into the near future, and we look forward to these types of activities. As members of the National Science and Technology Council's Nanoscale Science, Engineering, and Technology Subcommittee, which manages the NNI, EPA plays a leadership role in the coordination of federal activities concerning nanotechnology and the environment, and we look forward to continuing these kinds of efforts as we move toward the future.
Chairman BOEHLERT. Thank you, Doctor.
Dr. FARLAND. Thank you, Mr. Chairman.
[The prepared statement of Dr. Farland follows:]
PREPARED STATEMENT OF WILLIAM H. FARLAND
Introduction
Thank you, Mr. Chairman and Members of the Committee for the invitation to appear here today and provide testimony on nanotechnology research at the Environmental Protection Agency (EPA). I am William Farland, Deputy Assistant Administrator for Science for the Office of Research and Development. EPA is a leader in promoting research to develop environmental applications and understand potential implications of nanotechnology, and vigorously pursues collaborations with U.S. and international scientists and policy-makers. My purpose today is to describe our research needs in this area, and how EPA is going about meeting these needs.
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EPA recognizes that nanotechnology has the potential to improve the environment, both through direct applications to detect, prevent, and remove pollutants, as well as by using nanotechnology to design cleaner industrial processes and create environmentally friendly products. However, some of the same unique properties that make manufactured nanoparticles (which in the remainder of this testimony I refer to simply as ''nanoparticles,'' recognizing that our focus is on particles intentionally manufactured at the nanoscale) beneficial also raise questions about the impacts of nanoparticles on human health and the environment. The evaluation of potential nanoparticle toxicity is complex, possibly being regulated by a variety of physicochemical properties such as size and shape, as well as surface properties such as charge, area, reactivity, and coating type on the particle. As products made from nanoparticles become more numerous, the potential for release of nano-size particles into the environment may also increase. The EPA, under its various statutes, has an obligation to ensure that potential environmental risks are adequately understood and managed. Certain EPA programs are already reviewing information on nanomaterials to assess and understand risks and take control measures as needed. For example, EPA is reviewing pre-manufacture notifications on nanomaterials that have been received under Section 5 of the Toxic Substances Control Act. It is important that throughout our evaluation of nanotechnology, decision-making be informed by the best available scientific information.
EPA began funding research on nanotechnology under its Science to Achieve Results (STAR) program in 2001. Some 36 grants totaling nearly $12 million have been funded since that time to identify beneficial environmental applications, addressing prevention, sensors, treatment, and remediation of conventional pollutants using nanotechnology. In addition, through its Small Business Innovation Research program EPA has supported projects addressing nanotechnology applications.
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Beginning in 2003, EPA turned its focus to the potential environmental implications of nanotechnology and has now funded an additional 30 implications projects totaling approximately $10.4 million under the STAR program. This research is addressing potential human and environmental toxicity, exposure, and fate and transport of nanoparticles in the environment. EPA has partnered with the National Science Foundation, National Institute for Environmental Health Sciences (NIEHS), and National Institute for Occupational Safety and Health (NIOSH), which have funded additional projects under these solicitations. Currently, EPA and the three partner agencies are reviewing the proposals from the latest joint solicitation to make new funding decisions.
Research Needs
While some of EPA's research needs are shared by other federal agencies, EPA has particular needs to support its statutory mandates. To that end, EPA must set research priorities that reflect these program needs. EPA plans to issue its Nanotechnology White Paper, released in December 2005 as a review draft that describes EPA's nanotechnology research needs. This research is in the following broad areas: chemical identification and characterization, environmental fate, environmental detection and analysis, potential releases to the environment and human exposures, human health effects assessment, ecological effects assessment, and environmental applications.
Chemical Identification and Characterization
A number of properties will need to be considered in order to characterize nanoparticles for the purposes of evaluating hazard and assessing risk. Terminology and nomenclature also need to be standardized. EPA is participating in deliberations with the American National Standards Institute, the American Society for Testing and Materials, and the International Organization for Standardization regarding the development of terminology and chemical nomenclature for nano-sized substances, and will also continue with its own nomenclature discussions with the Chemical Abstracts Service.
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Potential Releases and Human Exposures
Workers may be exposed to particles during the production and use of materials made from nanoparticles, and the general population may be exposed to releases to the environment during these materials' production or use in the workplace, during the use of commercially available products containing nanoparticles, and during disposal and recycling stages. Workers who manufacture materials made from nanoparticles may be exposed to higher levels of nanoparticles than the general population, and therefore may need additional personal protective equipment. Research is needed to better understand these exposures.
Environmental Detection and Analysis
The challenge in detecting nanoparticles in the environment is not only their extremely small size but also because the metric of importance is unknown. Consequently we are currently unsure of what to measure and detect. The chemical properties of particles at the nanometer size may require new analytical and detection techniques. To that end, we need to assess available detection methods and technologies for nanoparticles in environmental media, and to develop a set of standard methods for the sampling and analysis of nanoparticles of interest in various environmental media.
Environmental Fate
As more products are developed using nanoparticles, there is increased potential for releases of nanoparticles into the environment. Particles may be released to the environment during their manufacture and processing, or as they break down during use, disposal, or recycling. We need to understand what happens to these particles as they are released into and move through the air, soil, and water.
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Human Health Effects
Very little data exist on the toxicity, hazardous properties, translocation, and ultimate fate of nanoparticles in humans. We need to understand whether adverse health effects may result from exposure to nanoparticles or their byproducts, by local toxic effects at the site of initial deposition as well as by systemic toxic responses. Toxicological assessment of manufactured nanoparticles will require information on the routes (inhalation, oral, dermal) that carry the greatest potential for exposure to nanoparticles.
Ecological Effects
Research is needed on the potential exposure and effects of nanoparticles on invertebrates, fish, and wildlife. Furthermore, dispersion of nanoparticles in the environment may result in novel byproducts or degradates that also may pose hazards. We need to understand the behavior of nanomaterials in aquatic and terrestrial environments, and nanoparticles' potential acute and chronic toxic effects. To do this, we need to develop and validate analytical methodologies for measuring nanoscale substances (both parent materials and metabolites/complexes) in the environment.
Environmental Applications
Nanotechnology can help create materials and products that will not only directly advance our ability to detect, monitor, and clean-up environmental contaminants, but also help us avoid creating pollution in the first place. By using less materials and energy throughout a product's lifecycle—such as by using highly reactive nanoparticles as more-efficient catalysts—nanotechnolgoy may contribute to reducing pollution and energy consumption. Research is needed to advance the use of nanotechnology to enhance environmental protection.
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EPA Research
Based on the fiscal year 2007 President's budget request of $8.6 million, EPA is developing a nanotechnology research framework for fiscal years 2007–2012 that is problem-driven, focusing on addressing the Agency's programmatic needs. EPA will conduct research to understand whether nanoparticles, in particular those with the greatest potential to be released into the environment and/or trigger a hazard concern, pose significant risks to human health or ecosystems, by looking at the life cycle of nanoparticles. Also, EPA will conduct research to identify approaches for detecting and measuring nanoparticles in the environment, and for using nanotechnology for pollution prevention and enhancing manufacturing processes, as well as to facilitate the development of nanotechnology-based materials in an environmentally benign manner.
This research program will be based on the recommendations from the EPA Nanotechnology White Paper, which was developed by a cross-agency committee working under the auspices of our Science Policy Council. Our research will be guided by the information needed to conduct assessments of risk to humans and the environment. We are uniquely positioned to lead in the ecosystem and exposure areas, due to our existing expertise in these areas. Also, because of expertise in areas such as fine particulate toxicology, we plan to engage in a limited amount of human health effects research. However, we also will look to partnerships and collaboration with other agencies to fill our research needs. For example, we are currently working with NIEHS to ensure that human toxicity research is conducted that is relevant and timely for environmental decision-making.
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Because the President's budget request proposes to significantly increase EPA's nanotechnology research budget in 2007, I believe the Agency is well positioned to examine the potential human health and ecological risks from nanoparticles.
Collaboration
To meet the research needs outlined here, we need a collaborative approach that will energize the research community, public and private. EPA scientists are leaders in explaining how we can use nanotechnology to improve our environment and how we can improve our understanding of any potential adverse effects resulting from the production, use, disposal and recycling of materials that contain nanoparticles. We intend to continue these efforts and to increase direct collaborations on the research discussed above.
As a member of the National Science and Technology Council's Nanoscale Science, Engineering and Technology Subcommittee, which manages the National Nanotechnology Initiative, EPA plays a leadership role in the coordination of federal activities concerning nanotechnology and the environment. The Agency is also a pivotal member of the Subcommittee's Nanotechnology Environmental and Health Implications (NEHI) working group, whose membership includes, among others, EPA, Food and Drug Administration, Consumer Products Safety Commission, NIOSH, Department of Defense, Department of Energy, and NIH. The NEHI has prepared a research needs document, in the development of which EPA has played a central role, that complements our white paper.
EPA is also engaged in international collaboration. For example, EPA is part of the Organization for Economic Cooperation and Development effort to address the topic of the implications of manufactured nanomaterials among its members under the auspices of the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology.
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Conclusion
EPA recognizes the potential of nanotechnology to clean up the environment, prevent pollution, and contribute to the sustainable use of resources. EPA is also committed to improving our understanding of the properties of nanoparticles, the behavior of nanoparticles in the environment, and the potential for unintended consequences for humans and the environment from exposure to nanoparticles. The Agency will continue to play a domestic and international leadership role to better understand the environmental issues surrounding this and other emerging technologies. Mr. Chairman, I would like to thank you and the Committee for inviting EPA to participate in this hearing and for giving us this opportunity to describe our nanotechnology research program. I would be happy to answer any questions that you may have.
Chairman BOEHLERT. Thank you, Dr. Farland.
Dr. Carim.
STATEMENT OF DR. ALTAF H. (TOF) CARIM, PROGRAM MANAGER, NANOSCALE SCIENCE AND ELECTRON SCATTERING CENTER, U.S. DEPARTMENT OF ENERGY
Dr. CARIM. I am sorry. I thought it was on already.
Mr. Chairman and Members of the Committee, good morning, and thank you for the opportunity to speak with you today about nanotechnology programs at the Department of Energy. My name is Altaf Carim, and I manage major nanoscience user facilities and coordinate nanoscience activities in the Office of Science at DOE. The longstanding support of this committee for scientific research and development, including that carried out within the Office of Science, is deeply appreciated and Mr. Chairman, I also want to add thanks for your longstanding leadership in this area.
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Nanoscale science and technology is, of course, a key area among those encompassed by the American Competitiveness Initiative. Collectively, these efforts do constitute vital investments that are essential to maintaining the U.S. leadership in innovation and its associated economic benefits.
The mission of DOE's Office of Science is ''to deliver the remarkable discoveries and scientific tools that transform our understanding of energy and matter and advance the national, economic, and energy security of the U.S.'' To address this mission, the Office of Science includes key portfolio components in two types of activities: fundamental research in support of long-term energy security and discovery science that enables the DOE missions, and forefront scientific user facilities for the Nation which provide the infrastructure for world leadership in science. Accordingly, our nanotechnology activities include both support of basic research at universities and National Laboratories, and the development and operation of major facilities for nanoscale research.
Nanotechnology research programs at DOE are part of the broad portfolio of programs in the Office of Science, and are supported through submissions to our core research program, the equivalent of a broad agency announcement, as well as through a variety of other occasional solicitations. Only a few such solicitations have concentrated specifically on nanotechnology. The Office of Science also has a small program that supports research on the ethical, legal, and societal issues in two primary areas: biotechnology and nanotechnology. Broadly, decisions on research programs are made through peer review and merit evaluation and through program managers' judgments on portfolio balance. The determination of priorities for solicitations and funding is also informed by DOE workshops, advisory groups, federal budget priorities, independent reports, and interagency discussions and documents, including the Strategic Plan and workshop reports of the National Nanotechnology Initiative, or NNI.
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With respect to major facilities, the development and operation by DOE of five Nanoscale Science Research Centers represents by far the largest component of the NNI investment in scientific infrastructure. Each of these centers serves as a resource to the entire scientific community, including researchers from other federal agencies such as the Environmental Protection Agency, and provides researchers access based on the scientific merit of their proposals. These centers are collocated with other major capabilities such as x-ray synchrotrons, neutron scattering facilities, electron microscopy centers, and advanced computing facilities to maximize the advantage of those tools for nanoscience research.
While not their primarily research mission, these user facilities will enable work, possible nowhere else in the United States, in environmental, health, and safety issues by providing widely-accessible capabilities for advanced synthesis, characterization, and properties measurement. Four of the NSRCs have completed construction of their specially-designed buildings and are now in operation and the fifth is still under construction.
Furthermore, DOE fully expects the Nanoscale Science Research Centers themselves to be ''best in class'' with respect to their own environmental, health, and safety practices. Just over a year ago, in September 2005, the Secretary of Energy issued a formal Secretarial Policy Statement on Nanoscale Safety, which I would ask to have included in the record, and it is attached to my testimony.
National Laboratory staff with environmental, health, and safety responsibilities at the Nanoscale Science Research Centers also constitute a working group which meets and teleconferences on a regular basis to share information and best practices.
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Interagency coordination has provided very valuable input in defining DOE's nanotechnology activities. The Department of Energy has participated in the NSET Subcommittee since the subcommittee's genesis in 2000, and prior to that was a member of the precursor Interagency Working Group of the same name. And in fact, DOE was one of the six initial agencies involved. The development of plans for the Nanoscale Science Research Centers, in particular, was in part a response to the need identified by the interagency group for such major facilities
I hope this testimony provides a fuller awareness of DOE's many activities in the field of nanoscience, including our attention to the environmental, health, and safety aspects
I appreciate your time and would be glad to address any questions you may have.
[The prepared statement of Dr. Carim follows:]
PREPARED STATEMENT OF ALTAF H. CARIM
Mr. Chairman, and Members of the Committee, good morning and thank you for the opportunity to speak with you today about nanotechnology programs at the Department of Energy. My name is Altaf Carim, and I manage major nanoscience user facilities and coordinate nanoscience activities in the Office of Science at DOE. The longstanding support of this committee for scientific research and development, including that carried out within the Office of Science, is deeply appreciated. Nanoscale science and technology is a key area among those encompassed by the American Competitiveness Initiative. Collectively, these efforts constitute vital investments essential to maintaining U.S. leadership in innovation and its associated economic benefits.
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The mission of DOE's Office of Science is ''. . .to deliver the remarkable discoveries and scientific tools that transform our understanding of energy and matter and advance the national, economic, and energy security of the U.S.'' To address this mission, the Office of Science includes key portfolio components in two types of activities: fundamental research in support of long-term energy security and discovery science that enables the DOE missions, and forefront scientific user facilities for the Nation which provide the infrastructure for world leadership in science. Accordingly, our nanotechnology activities include both support of basic research at universities and National Laboratories, and the development and operation of major facilities for nanoscale research.
Nanotechnology research programs at DOE are part of the broad portfolio of programs in the Office of Science, and are supported through submissions to our core research program (the equivalent of a broad agency announcement) as well as through a variety of other occasional solicitations. Only a few such solicitations have concentrated specifically on nanotechnology. The Office of Science also has a small program that supports research on the ethical, legal, and societal issues in two primary areas: biotechnology and nanotechnology. Broadly, decisions on research programs are made through peer review and merit evaluation and through program managers' judgments on portfolio balance. The determination of priorities for solicitations and funding is also informed by DOE workshops, advisory groups, federal budget priorities, independent reports, and interagency discussions and documents, including the Strategic Plan and workshop reports of the National Nanotechnology Initiative (NNI).
Procedures and criteria in the solicitation selection process are consistent with the Code of Federal Regulations at 10 CFR Part 605, with selection and evaluation based on the following criteria which are listed in descending order of importance:
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(1) Scientific and/or technical merit or the educational benefits of the project;
(2) Appropriateness of the proposed method or approach;
(3) Competency of applicant's personnel and adequacy of proposed resources;
(4) Reasonableness and appropriateness of the proposed budget; and
(5) Other appropriate factors, established and set forth in a notice of availability or in a specific solicitation.
With respect to major facilities, the development and operation by DOE of five Nanoscale Science Research Centers represents by far the largest component of the NNI investment in scientific infrastructure. Each of these centers serves as a resource to the entire scientific community (including researchers from other federal agencies such as the Environmental Protection Agency) and provides researchers access based on the scientific merit of their proposals. The Nanoscale Science Research Centers are collocated with other major capabilities such as x-ray synchrotrons, neutron scattering facilities, electron microscopy centers, and advanced computing facilities to maximize the advantage of these tools for nanoscience research.
While not their primarily research mission, these user facilities will enable work—possible nowhere else in the United States—in environmental, health, and safety issues by providing widely-accessible capabilities for advanced synthesis, characterization, and properties measurement. Four of the NSRCs have completed construction of their specially-designed buildings and are now in operation at Argonne National Laboratory, Lawrence Berkeley National Laboratory, Oak Ridge National Laboratory, and jointly at Sandia and Los Alamos National Laboratories. The fifth, at Brookhaven National Laboratory, is still under construction.
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Further, DOE fully expects the Nanoscale Science Research Centers to be ''best-in-class'' with respect to their own environmental, health, and safety practices. Just over a year ago, in September 2005, the Secretary of Energy issued a formal Secretarial Policy Statement on Nanoscale Safety, which I would ask to have included in the record (DOE P 456.1, attached). National Laboratory staff with environmental, health, and safety responsibilities at the NSRCs also constitute a working group which meets and teleconferences on a regular basis to share information and best practices.
Interagency coordination has provided very valuable input in defining DOE's nanotechnology activities. The Department of Energy has participated in the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council from the subcommittee's genesis in 2000, and prior to that was a member of the precursor Interagency Working Group of the same name—in fact, DOE was one of the six initial agencies involved in NSET and the NNI, which has now grown to encompass 25 entities. The development of plans for the Nanoscale Science Research Centers was in part a response to the need identified by the interagency group for such major facilities. DOE is actively involved in the NSET subcommittee itself, on which I currently serve as Co-Chair, and its various working groups, including that on Nanotechnology Environmental and Health Implications. DOE and national laboratory staff also participate in related activities such as development of standards necessary for effective understanding of environmental, safety, and health implications through organizations like the American National Standards Institute.
I hope this testimony provides a fuller awareness of DOE's many activities in the field of nanoscience, including our attention to the environmental, health, and safety aspects of this vital area of science. I appreciate your time and would be glad to address any questions you may have.
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BIOGRAPHY FOR ALTAF H. (TOF) CARIM
Education
S.B. in Materials Science and Engineering, Massachusetts Institute of Technology, 1982
M.S. in Materials Science and Engineering, Stanford University, 1984
Ph.D. in Materials Science and Engineering, Stanford University, 1989
Experience
Tof Carim joined the Office of Basic Energy Sciences at DOE in September 2001 as a Program Manager with primary responsibility for activities in the structure and composition of materials. His present duties include serving as the DOE program manager for five Nanoscale Science Research Center user facilities, representing DOE on and co-chairing the interagency Nanoscale Science, Engineering, and Technology subcommittee of the National Science and Technology Council, and overseeing operations of three electron beam micro-characterization user facilities.
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Prior to joining DOE, Dr. Carim was at Pennsylvania State University (Penn State), where he was on the faculty for eleven years, most recently as Chair of the Electronic and Photonic Materials Program. He previously held summer positions at Bell Laboratories and the Xerox Palo Alto Research Center, did graduate work under support from Philips Research Laboratories Sunnyvale, held a post-doc at the Philips Natuurkundig Laboratorium in The Netherlands, and for two years was a faculty member at the University of New Mexico. He also was a visiting investigator at the Carnegie Institution of Washington on a sabbatical leave.
Dr. Carim's primary expertise is in microstructural and microchemical characterization of materials, with research contributions in a variety of areas including semiconductor interfaces, superconducting and ferroelectric oxide thin films and ceramics, crystal structure determination, crystalline defects, joining of ceramics and composites, development of anisotropic microstructures, electron holography, and morphology of nanoparticles and nanowires. He has authored or co-authored over 85 research publications in these areas, including two book chapters, has edited two volumes, and has given more than 70 conference, seminar, and other presentations. He has been active in numerous professional societies, has organized a number of technical meetings and symposia, and has held editorial roles with several journals. His awards and honors include recognition as an Office of Naval Research Young Investigator and receipt of an AIST Foreign Researcher Invitation to lecture in Japan.
Chairman BOEHLERT. Thank you.
Dr. Maynard.
STATEMENT OF DR. ANDREW D. MAYNARD, CHIEF SCIENCE ADVISOR, PROJECT ON EMERGING NANOTECHNOLOGIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS
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Dr. MAYNARD. Thank you, Chairman Boehlert, Ranking Member Gordon, and Members of the Committee for holding this hearing and for inviting me to speak. My name is Andrew Maynard. I am the chief science advisor for the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, and this is also a partnership with the Pew Charitable Trusts. But obviously, my comments here are my own personal opinions.
I have had over 15 years research experience looking at nanoscale materials. I have also spent some time in the Federal Government, and I have had the great pleasure of co-chairing the NEHI Working Group at its inception with my colleague, Dr. Alderson, who is sitting here.
I would like to begin my testimony by telling you a story.
Imagine a successful businessman who decides to build a new mansion. He gathers together 20 of the best builders in America and tells them to construct his dream home. Sure enough, the details within the mansion are impeccable: Italian marble countertops, vaulted ceilings, exotic hardwood floors. Yet, without the direction of an architect or master plan, the overall building is an incoherent mess.
The point, I think, is obvious: you can't embark on a complex project unless you know where you are going and have at least some idea of how to get there. Yet, this seems to be where we are with research aimed at ensuring the safety of emerging nanotechnologies.
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Without a doubt, the Federal Government is funding innovative and ground-breaking research in this area. As my colleagues on this panel have just alluded to, you have heard some excellent examples of what they are doing. But these programs arise from the vision of individual scientists and research leaders within the agencies, and only coincidentally give the fleeting illusion of coherence.
Nanotechnology, as has already been said, is no longer a scientific curiosity. It is already in the workplace, the environment, and the home. If we are to realize the benefits, we need a master plan for identifying and reducing potential risks. This plan should include a top-down research strategy, sufficient funding to do the job, and mechanisms to ensure resources are used as effectively as possible.
Let me address each of those points in turn.
Nanotechnology, as my colleague from EPA has said, is complex. In fact, it is far too complex for disjointed, bottom-up research agendas to answer critical questions on safety. The only viable alternative is a top-down, strategic research framework. This should identify what needs to be done and when in order to provide regulators, industry, and others with the knowledge they need to ensure safe nanotechnologies.
Without the high-level perspective embodied in a top-down strategy, the emergence of safe nanotechnologies will be coincidental rather than intentional. But a strategy without sufficient resources will be ineffective. In my estimation, the Federal Government needs to invest a minimum of $100 million in targeted research over the next two years in order to lay a strong science-based foundation for safe nanotechnology. This is largely in addition to current research funding, which, from my analysis, is closer to $11 million per year rather than the National Nanotechnology Initiative's stated $37 million to $44 million per year.
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Targeted research will address specific problems involving the potential impact of nanotechnology, but it also must be complemented by more basic exploratory research that develops the scientific knowledge needed to identify and address future risks.
And finally, mechanisms. Mechanisms are needed to support and enable the right research. These must ensure targeted research is led by agencies charged with protecting human health and the environment and supported by those agencies with the resources and the ability to do the job. But they must also support partnerships that provide innovative solutions to new challenges. In particular, government and industry need to work together to address specific issues, and on this point, I am recommending that a jointly funded nanotechnology and health impact research initiative is established within the Health Effects Initiative—Institute. Sorry.
So in closing, I come back to the fundamental question driving this hearing: ''Do federal agencies have a coherent, adequately resourced research strategy, which will answer the questions industry needs to develop nanotechnology safely and which will ensure the public that nanotechnology is being managed wisely?''
If the report that we just had released this morning from the NEHI Working Group is anything to go by, I must conclude that there is still a long, long way to go. Lists of research needs are useful, and I don't want to detract from the expertise represented in this report. I think it is a very useful report. But a list is not a research strategy, and without a strategy, it becomes very, very hard, indeed, to differentiate truly relevant research from that which, in all honesty, isn't relevant at all.
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In the meantime, people are asking, ''What do I do to ensure the safety of nanotech products?'' To answer them, the government needs a master plan, and it needs it soon.
Thank you.
[The prepared statement of Dr. Maynard follows:]
PREPARED STATEMENT OF ANDREW D. MAYNARD
I would like to thank Chairman Sherwood Boehlert, Ranking Member Bart Gordon, and the Members of the House Committee on Science for holding this hearing on ''Research on Environmental and Safety Impacts of Nanotechnology: What Are the Federal Agencies Doing?''
My name is Dr. Andrew Maynard. I am the Chief Science Advisor to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars. I am an experienced researcher in the field of nanomaterials and their environmental and health impacts, and have contributed substantially in the past fifteen years to the scientific understanding of how these materials might lead to new or different environmental and health risks. I was responsible for stimulating government research programs into the occupational health impact of nanomaterials in Britain towards the end of the 1990's and have spent five of the past six years developing and coordinating research programs at the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) that address the safety of nanotechnologies in the workplace. While at NIOSH, I represented the agency on the Nanoscale Science, Engineering and Technology (NSET) Subcommittee of the National Science and Technology Council (NSTC), and was co-chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group from its inception.
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The Project on Emerging Nanotechnologies is an initiative launched by the Woodrow Wilson International Center for Scholars and The Pew Charitable Trusts in 2005. It is dedicated to helping business, government and the public anticipate and manage the possible health and environmental implications of nanotechnology. As part of the Wilson Center, the Project on Emerging Nanotechnologies is a non-partisan, non-advocacy organization that collaborates with researchers, government, industry, non-governmental organizations (NGOs), and others concerned with the safe applications and utilization of nanotechnology.
Our goal is to take a long-term look at nanotechnologies; to identify gaps in the nanotechnology information, data, and oversight processes; and to develop practical strategies and approaches for closing those gaps and ensuring that the benefits of nanotechnologies will be realized. We aim to provide independent, objective information and analysis that can help inform critical decisions affecting the development, use, and commercialization of responsible nanotechnologies around the globe.
In short, both the Wilson Center and The Pew Charitable Trusts believe there is a tremendous opportunity with nanotechnology to ''get it right.'' Societies have missed this chance with other new technologies and, by doing so, have made costly mistakes.
As a scientist, I am awed by the vast potential of nanotechnology. I also understand the thrill of making new discoveries and turning them into societal or economic gain. But through my work in occupational health, I also understand the very real dangers of proceeding without due caution. Make no mistake, nanotechnology is different, and there will be some materials and products developed under this banner that have the potential to cause harm. The challenge we face is how to recognize and manage this possibility ahead of time and deal with it. The stakes are high: not only are human health and the environment potentially at risk, but so is the ''health'' of nano-commerce. If investors and consumers reject nanotechnology through fear and uncertainty, missed opportunities in areas like medical treatment and energy production could deal a severe blow to the quality of life and the future economic well-being of this country.
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Are current federal and private research efforts adequate to address concerns about environmental and safety impacts of nanotechnology? Are there gaps in the portfolio of federal research currently underway; if so, in what areas?
The long-term solution must be to reduce uncertainty about the possible health and environmental impacts of nanotechnology through systematic scientific research. Perhaps uniquely in regards to an emerging technology the Federal Government and industry have moved to understand the potential risks of nanotechnology at an early stage. The 21st Century Nanotechnology Research and Development Act(see footnote 29) and the NEHI Working Group within NSET are testaments to the attempts of this government to act early to minimize potential risks. Yet these good intentions do not seem to have translated into hard information regarding how to avoid risks and develop safe nanotechnologies. The fact is that nanotechnology is a reality now—in workplaces and in the marketplace: Every day, people are asking questions like ''how safe is this product?'', ''how do I protect myself?'', and ''what happens to this material in the environment?'' These are questions that we do not yet have answers for, and for which we do not yet have a clear pathway to finding answers anytime soon. Our inability to provide clear and timely answers can ultimately jeopardize the ability of government and industry to reap the economic and social benefits of billions of dollars of R&D investments.
Part of the problem is that nanotechnology is complex—no single agency, research group or even scientific discipline is able to grapple with the challenges it presents without collaborating and working with others. This is not a problem we can solve piecemeal—effective solutions will require top-down direction and coordination if we are to remove the uncertainty surrounding nanotechnology and potential risk.
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In a recent study, Nanotechnology: A Research Strategy for Addressing Risk, I considered what needs to happen if critical research questions are to be addressed.(see footnote 30) Drawing on previously published papers from government, industry, academia and NGOs, the report—which is included with this testimony—identifies and prioritizes critical research needs and makes specific recommendations on how to develop an effective strategic research framework. In assessing the current risk research situation, it became very clear that current federal coordination of nanotechnology research is not sufficient to ensure that timely and relevant information on minimizing and managing nanotechnology's risks is being developed.
In particular, the relevant agencies are under pressure, because they are under-resourced and struggling without adequate leadership or broad strategic direction. I see no evidence of foresight; of the government looking longer-term to identify emerging risks that may appear as nanotechnology becomes more complex and converges with biotechnology. Without better foresight, there is little hope that the government will be positioned to underpin regulation with good science, or provide solid answers to questions that the public will inevitably raise about the risks of nanotechnologies. Individual agencies such as NIOSH, the Environmental Protection Agency (EPA), the National Institutes of Health (NIH) and the National Science Foundation (NSF) are doing their best to develop research programs from the bottom-up—in some cases with very limited resources. But these disconnected research programs will not make a significant difference in ensuring safe nanotechnologies without sweeping changes to the way nanotechnology risk research is directed and supported at the federal level.
The current approach leads to some perplexing oddities. For example, it is widely accepted that research into assessing and preventing health risks in the workplace is critical to the success of nanotechnologies. However, the anticipated increase in risk-related research funding for the National Science Foundation between 2006 and 2007 (an increase of $3.6 million, from $22.1 million to $25.7 million), far exceeds the total requested nanotechnology risk research budget for the National Institute for Occupational Safety and Health in 2007 ($3 million).(see footnote 31) If these figures accurately reflect the Federal Government's current priorities, then it is clear that ensuring safe nanotechnology workplaces is not high on the list—particularly since the mandate of NSF is basic research and not mission-driven environmental and human-health studies.
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Of course, numbers alone can be misleading: What is important is the research that those numbers represent. It is obvious that without knowing where you are, you cannot plan how to get where you want to be. If federal research addressing the potential risks of nanotechnology is to be strategic, transparent and relevant, we need to know what is being done and what is being missed. Unfortunately, information as to what risk-related research is currently being carried out is not readily available from or even within the Federal Government. National Nanotechnology Initiative (NNI) representatives have noted that it is hard to tease out risk-related projects from the general mix of the government's nanotechnology research portfolio. However, without a more precise understanding of what U.S. Government funded investigators are studying, the reported figures tell us nothing about whether the right questions are being asked—and answered—in order to ensure nanotechnology's safe management. It is important to emphasize that this research by the government is being supported by public funds and it is ultimately the public—as workers or consumers, for instance—that may bear many of the potential risks related to nanotechnology. Project-by-project data on what the government is funding to understand and mitigate risks should be placed in the public realm now.
What should be the priority areas of research on environmental and safety impacts of nanotechnology? How should the responsibility for funding and conducting this research be divided among the federal agencies, industry, and universities?
Recognizing this information gap, last year the Project on Emerging Nanotechnologies compiled and published an inventory of current nanotechnology risk-related research.(see footnote 32) The inventory is publicly accessible on-line, fully searchable, and classifies research to allow a clear picture of what is currently being done. The inventory first and foremost confirms that a substantial body of research is being funded to try and understand the potential impacts of nanotechnology on human health and the environment. In 2005, we estimate that the annual U.S. Federal Government in research with some relevance to nanotechnology risks was over $30 million. However, it is unclear how relevant this research is to reducing the current uncertainty over nanotechnology's health and environmental impacts, providing guidance for emerging oversight regimes at agencies such as EPA and FDA, or answering increasing numbers of public questions and concerns over the safety of nanotech-related products and applications.
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Two examples serve to highlight an apparent disconnect between the Federal Government's research agenda and what is needed to illuminate any hazards related to nanotechnology. The first example draws on the Project on Emerging Nanotechnologies' inventory of nanotechnology-based consumer products,(see footnote 33) and compares the prevalence of nanomaterials in these products to research into their potential impacts. In Figure 1, I compare research into the impact of six nanomaterials—carbon, silver, silica, titanium, zinc and cerium—to the number of consumer products known to be using these materials.
Although this is a very subjective exercise, it shows the vast majority of the material-specific risk research is focused—disproportionately it would seem—on carbon-based nanomaterials. At the time of the analysis, carbon-based nanomaterials accounted for just 34 percent of listed consumer products, while silver accounted for 30 percent of listed products, and silica and metal oxides such as silica, titanium dioxide, zinc oxide and cerium oxide accounted for 36 percent of listed products. In other words, risk research does not appear to be in step with current market realities.
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The second example considers the number of research projects that are probing the potential effects of nanomaterials on different parts of the body—the lungs, the skin, the central nervous system, the cardiovascular system and the gastrointestinal tract. Figure 2 indicates that current human hazard research appears to focus heavily on nanomaterials in the lungs (24 projects), while no projects are specifically addressing the potential effects of nanomaterials in the gastrointestinal tract. Given the large number of current and future nano-products that are intended to be eaten—such as food and nutritional supplements—this is a curious and serious omission.
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These examples indicate that current federally funded research is not addressing the general range of risks that may already be present in the market and that risk research is not guided by a careful consideration of needs—today or tomorrow. Why is there so little research on nanomaterials in use now? Is the emphasis on lung impacts due to careful consideration of relative risks, or because pulmonary toxicologists are more active in this field?
Having cataloged information on current risk-research, the Project on Emerging Nanotechnologies (PEN) was able to go back and check the validity of published government funding figures. Comparing estimates of federal spending on nanotechnology risk research from our research inventory to figures published by NSET tells an interesting story. Table 1 compares the NSET figures with PEN-estimated annual funding for research which is highly relevant to understanding risk and research which has some degree of relevance.
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Highly-relevant research covers projects with the specific aim of understanding the potential risks of nanotechnology, and includes areas such as using a life-cycle approach to evaluate the impact of future nanotechnologies (EPA), and evaluating assessment methods for nanoparticles in the workplace (NIOSH). On the other hand, research with some degree of relevance includes projects that are not focused on nanotechnology risk, but nevertheless have the potential to shed some light on our understanding of risk. Examples include studying the formation of nano-droplets (NSF), developing biosensors for metals (EPA) and controlling exposure to welding fumes (NIOSH).
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There is close agreement between the NSET estimate for highly-relevant risk research and the Project on Emerging Nanotechnologies estimate of research with some degree of relevance. When the Project on Emerging Nanotechnologies estimate of research that is highly relevant to engineered nanomaterials is compared to the NSET estimate, the gap widens considerably. Based on all available information, we estimate that only $11 million per year is being spent on research that is highly relevant to nanotechnology risks, compared to NSET's estimate of $38.5 million per year. That gap is too large to be explained by the different reporting periods or a lack of agency disclosure.
What elements should the forthcoming report on research needs produced by the National Nanotechnology Environmental and Health Implications Working Group contain to adequately guide federal research investment in this area? What additional steps are needed to improve management and coordination of federal research on the environmental and safety impacts of nanotechnology?
The evidence before us strongly suggests that current federal research efforts are not adequate to address concerns arising about the environmental, health and safety impacts of nanotechnology. There are clear gaps in the research portfolio in determining potential hazard, evaluating exposure, controlling releases of nanomaterials, determining potential impact and managing risk. But I am more concerned over the lack of an apparent top-down strategy that couples risk research to real information needs. Without such a strategy, it is next to impossible to identify clearly where the gaps are and how best to address them. Implicit in a strategy is the setting of hard priorities, the linking of these priorities to actual multi-year funding levels, and the development of metrics to measure results over time. There is a large difference between a strategy and a list of research needs.
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A government strategy must also consider and integrate industry issues and, ultimately, enable collaborative funding. Much less information is available on industry-based risk research and testing programs. Some initiatives shine out, such as the research consortium led by DuPont to develop measurement methods and research supported by the International Council On Nanotechnology (ICON) into good workplace practices. But these are the exception—most nanotechnology industries are looking to the government for guidance on what should be done and are coming up against a brick wall. This means that we not only lack a coherent government strategy, but we lack a coherent public-private sector strategy, and we certainly have no international strategy to address risks in a timely manner.
With the right leadership from the Federal Government, effective research programs and partnerships can be developed that will lead to safe nanotechnologies. In the attached report, I make a number of recommendations on what needs to be done in the next two years. Here, I would like to focus on three specific recommendations for developing a strong federal research agenda that simultaneously reduces uncertainty as fast as possible and serves the needs of regulators, industry and other stakeholders:
Develop a top-down strategic risk-research framework within the Federal Government;
Adequately fund strategic risk-focused research, with an investment of #at least $100 million, over the next two years; and
Support a joint government-industry funded cooperative science organization, with a five-year plan to systematically address the human health impacts of engineered nanomaterials through independent, targeted research.
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Although not comprehensive, I believe making advances in each of these three areas, as I will explain in more detail, will lead to effective research programs that serve the needs of various end-users.
Develop a top-down strategic risk-research framework within the Federal Government.
Nanotechnology is no longer confined to the laboratory; it is a commercial reality now.(see footnote 34) As our ability to make new materials, devices and products through nanoscale engineering becomes increasingly sophisticated, researchers, workers and the public are raising real concerns over what the possible impacts to their health and the environment will be. These are concerns that can only be addressed through systematic, targeted and coordinated research.
Bottom-up, or investigator and agency-driven research, is highly effective at generating new knowledge. However, it will never have the context and perspective to holistically address issues arising from technology development and implementation. Instead, a top-down approach is essential, one that maps out necessary areas of research, prioritizes critical needs and provides support and direction for research agencies. In effect, a top-level framework is needed that enables scientists and research agencies to do their job as effectively as possible, to the best of their ability.
Where resources are limited, a top-down approach is the only way of ensuring that the necessary research is done within budgetary constraints and in a timely manner. The danger of not coordinating direction and resources from the highest levels is that research becomes unfocused and untargeted—and ultimately ineffective. It is irresponsible to spend millions of dollars on building a better microscope in the name of risk research when we cannot tell workers how effective their respirators are when working with nanomaterials!
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An effective top-down strategic framework must identify and prioritize critical research needs within the context of oversight and regulation. But it must also have teeth—it must have the authority to ensure that research priorities can be met through the provision of sufficient resources, the support of key agencies and the use of effective and relevant research and development mechanisms. It also must enable collaboration and partnerships between researchers, agencies and other organizations. As I have mentioned previously: nanotechnology is complex, and progress will only be made by working together.
While the NEHI Working Group has been effective in getting research agencies talking about risk, it has shown little evidence of leadership in setting and implementing a strategic research agenda. Although the NEHI Terms of Reference focus on supportive roles of information sharing and communication,(see footnote 35) the Working Group has no clear authority to direct research from the top down. To be truly effective in removing uncertainty surrounding the potential impacts of nanotechnologies, a new interagency oversight group should be established with authority to set, implement and review a strategic risk research framework. This group would be responsible for developing a top-level strategic framework that would serve as a guide for the coordination and conduct of risk-related research in relevant agencies. It would have the authority to set and implement a strategic research agenda and assure that agencies are provided with appropriate resources to carry out their work. The group would direct efforts to provide a strong scientific basis for regulatory decisions, thus bridging the existing gap between the need for oversight and our poor technical understanding of nanotechnology risks. It would also ensure that the results of risk-relevant research are put to practical uses, including education and outreach programs. In addition, the group would ensure that risk-related research is coordinated between industry and government and between the U.S., other countries and international organizations.
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In order to establish a long-term research agenda, the group must draw on the expertise of stakeholders, as well as government and non-government experts. I would strongly recommend that the National Academies are commissioned to conduct an independent, rolling review of research needs and priorities, which informs the strategic risk research framework.
Adequately fund strategic risk-focused research, with an investment of at least $100 million, over the next two years.
Once a research strategy is in place, it must be funded at realistic levels if it is to be successful. In my analysis of short-term strategic needs, I estimated the minimum level of funding needed to address critical questions by estimating the cost of the most important immediate research areas. From this analysis, a minimum of $100 million should be invested in targeted, highly relevant nanotechnology risk research over the next two years if significant progress is to be made. This is a substantial increase in the estimated $11 million per year currently being spent on risk-specific research.(see footnote 36) Funding should be tied to a top-level strategic risk research framework, and it should support agencies with missions and competencies to assess and reduce harm to people and the environment, such as NIOSH, EPA and the National Institute of Environmental and Health Sciences (NIEHS). But, it should also leverage the research expertise and facilities of agencies such as the Department of Energy (DOE) and NSF.
Critical research is needed that addresses risk assessment, environmental impact, human health impact and hazard prediction. In Table 2, I outline the highest research priorities—based upon my previously published analyses of research needs—and identify agencies that are ideally placed to lead these research efforts.
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Support the formation of a joint government-industry funded cooperative science organization, with a five-year plan to systematically address the human health impact of engineered nanomaterials through independent, targeted research.
The success of a strategic risk research framework for nanotechnology will depend critically on the mechanisms used to implement research. Federally-funded research must be systematic and targeted, if it is to answer questions being asked by industry and the public. But progress will also depend on collaborating and partnering with other stakeholders—particularly industry.
Industries investing in nanotechnology have a financial stake in preventing harm, manufacturing safe products and avoiding long-term liabilities. Yet, with a few exceptions, most of the questions that need answering are too general to be dealt with easily by industry alone. Perhaps more significantly, the credibility of industry-driven risk research is often brought into question by the public and NGOs as not being sufficiently independent and transparent. It seems that the current state of knowledge is sufficient to cast doubt on the safety of some nano-industries and products, but current information lacks the credibility for industry to plan a clear course of action on how to mitigate potential risks. Getting out of this ''information trap'' is a dilemma facing large and small nanotechnology industries alike.
One way out of the ''trap'' is to establish a cooperative science organization, tasked with generating independent, credible data that will support nanotechnology oversight and product stewardship. The organization would leverage federal and industry funding to support targeted research into assessing and managing potential nanotechnology risks. The success of such an organization would depend on four key attributes:
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Independence. The selection, direction and evaluation of funded research must be science-based and must be fully independent of the business and views of partners in the organization.
Transparency. The research, reviews and the operations of the organization must be fully open to public scrutiny.
Review. Research supported by the organization must be independently and transparently reviewed.
Communication. Research results must be made publicly accessible and fully and effectively communicated to all relevant parties.
A number of research organizations have been established over the years that comply with some of these criteria. Yet, perhaps the organization most successful and relevant to nanotechnology is the Health Effects Institute (HEI).
HEI was established in 1980 as a non-profit research institution focused on providing ''high-quality, impartial, and relevant science'' around the issue of air pollution and its health impacts.(see footnote 37) The Institute is committed to supporting risk-relevant research through anticipating the needs of policy-makers and scientists and by identifying the underlying questions propping up policy arguments and research priorities. Additionally, the production of timely scientific evidence is crucial to allow for decisions to be made within appropriate product development cycles.
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The HEI research model is unique in a number of ways. New research projects are chosen based on a competitive proposal process. This project selection process is similar to those employed by NSF and NIH, but it includes added attention to the policy relevance of scientific research. Once projects are selected for support, HEI issues contracts—not grants—to investigators. This is a unique component of the HEI process, and it allows the organization to benefit from the most creative proposals from the science community but still have much greater control over the scope of work and the final products to ensure their relevance to decisions. Close control over research enables HEI to aggressively manage investigations by monitoring progress and terminating projects that are not meeting established standards.
Once projects are funded, strict quality control is followed. Both HEI staff and independent investigators audit and review project quality. HEI's strict adherence to their quality control guidelines and rigorous peer reviews serves as potent defense against possible detractors. While this quality control does come at the cost of burdening investigators with more numerous reviews, it also serves to strengthen the validity of the data when applied in the policy realm and has raised HEI to a place among the most respected research organizations in the world.
Finally, supported research undergoes independent peer review and policy relevance critique. This process allows for thorough review prior to publication of a comprehensive report by HEI. The findings of any dissenting critiques are published along with final reports. In turn, all results are openly published in HEI's reports, both positive and negative, so that industry professionals and policy-makers can better understand how the investigators reached their conclusions.(see footnote 38) Since these results are presented in a highly transparent manner and are available at varying levels of detail, they are accessible to a wide variety of audiences. In addition, after reports are released, HEI monitors their use and strives to ensure that the full range of conclusions is considered by decision-makers in order to maintain their scientific integrity.(see footnote 39)
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HEI has funded over 250 studies in North America, Europe and Asia on a variety of topics, including carbon monoxide, air toxics, nitrogen oxides, diesel exhaust, ozone and particulate matter. The organization credits its success to five key factors: effective governance, joint industry-government funding, quality science, no advocacy and communication. Members constituting the HEI Board of Directors are chosen based upon their independence of any interests that could constitute bias, and this level of independence is extended down through the committees and staff. Individuals selected to the board are dually approved by stakeholders on both sides. The board of directors is charged with screening for potential conflicts of interest, overseeing staff, appointments to panels and the selection of researchers.
The HEI model is ideally suited to generating the credible and relevant information necessary to develop safe nanotechnologies. Developing a program using such a model would complement federal research into the potential risks of nanotechnology and would provide industry and regulatory agencies with needed information on managing possible health and environmental impacts. HEI could well be used as a template for establishing a separate ''Nanotechnology Effects Institute.'' But it would be more expedient to develop a nanotechnology risk research program within HEI. For this to occur, four conditions would need to be met:
Commitment by HEI to develop a nanotechnology risk research program.
Informal discussions with HEI have indicated a willingness to consider extending the Institute's research portfolio to addressing nanotechnology and potential risks. Successful development of such a research program will depend on long-term funding commitments from government and industry and a targeted, relevant research agenda.
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Commitment from the Federal Government to jointly fund research.
A successful program will depend on matched federal-industry funding, over a minimum of five years. Federal funding levels of at least $10 million over that time frame will be needed to ensure a coherent, relevant and influential research program and to attract industry funding. Currently, most government funding for HEI comes from EPA, with one half from the research arm and one half from the program/regulatory side. This allows for a tight link between research and regulation and the provision of a solid scientific underpinning for oversight. This approach can be followed for nanotechnology but should be expanded to consider research needs of agencies beyond EPA, such as FDA.
Commitment from industry to jointly fund research.
Likewise, establishing a successful research program will depend on a matching financial commitment from industry of at least $10 million over the next five years. Provisions should be made to integrate research issues from small business and start-up firms.
A relevant and robust strategic research agenda.
The success of a HEI-based nanotechnology risk research program will depend on identifying research areas that complement federal research, while responding directly to industry needs. Based on my analysis of critical research needs, I would propose that the initial emphasis of such a research agenda should focus on understanding and reducing the potential toxicity of engineered nanomaterials in humans. Table 3 lists a suite of research projects, along with estimated funding levels, which could form the backbone of a credible five-year research program. Of course, an expert oversight committee convened by an organization like HEI could—with broad input from the science and regulatory communities—review these priorities rapidly and finalize a set of targeted priorities to be sought in a first Request for Applications.
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It must be emphasized that this proposed program would complement, and not replace, either federal or industry research programs and that the estimated $20 million over five years is in addition to funding levels recommended for government-specific research.
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Conclusions
Nanotechnology is a reality now, and our ability to produce ever-more sophisticated materials, processes and products by engineering at the nanoscale will only increase over the coming years. Yet our understanding of the potential environmental, safety and health impacts of these emerging technologies is rudimentary at best.
Government and industry have been commendably astute in recognizing the possibility of new risks arising from emerging nanotechnologies at an early stage. But over a decade after the first indicators of nanostructured material-specific hazards were published, risk-based research remains poorly focused and under funded. Current federal research programs are unlikely to provide answers where they are most needed, and needed they are—especially since a proper understanding of risks is the only way to assure the emergence of economically viable technologies that do not harm people or the environment.
In this testimony, I have examined where current research strategies are lacking, and what can be done to ensure that future research is effective in reducing uncertainty surrounding the safety of nanotechnologies. In particular, I highlighted the need to develop a top-down strategic risk-research framework within the next six months and the need to adequately fund risk research—with an investment of at least $100 million over the next two years. I also proposed establishing a five-year, $20 million joint government-industry risk research partnership through the Health Effects Institute that will complement federal research initiatives.
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As the recommendations presented above begin to be implemented, it is clear that a host of questions remain to be addressed, including:
How are federal agencies ensuring that nanotechnology risk research information is being made widely available to the public, researchers, and small businesses?
How can the risk-related research needs of small nanotechnology businesses and start-ups be integrated into a comprehensive government-industry strategy?
How is the Federal Government translating risk-based research into effective guidance on working with and using nanotechnology-based products as safely as possible?
What plans does the Federal Government have to closely coordinate risk research at a global level?
What processes are in place that will allow the government to better anticipate and address future risks, especially as nanotechnology becomes more complex and converges with biotechnology?
How much is the Federal Government spending to design and engineer risks out of nanotechnology processes and products (rather than just addressing them after the fact)?
In closing, let me say that I have tremendous respect for the researchers who are working to understand the potential impacts of nanotechnology on human health and the environment. It is through their efforts that we now know many of the key issues that need to be addressed in order to make nanotechnology safe. However, for these researchers and research directors to be effective, they must be better supported with the necessary financial, human and strategic resources that they need. By taking action now, we have the opportunity to realize the full potential nanotechnology has to offer, without creating a legacy of harm to human health and the environment.
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BIOGRAPHY FOR ANDREW D. MAYNARD
Dr. Andrew Maynard serves as the Science Advisor to the Project on Emerging Nanotechnologies. He is internationally recognized as a research leader and lecturer in the fields of aerosol characterization and the implications of nanotechnology to occupational health. He trained as a physicist at Birmingham University (UK), and after completing a Ph.D. in ultra-fine aerosol analysis at the Cavendish Laboratory, Cambridge University (UK) joined the Aerosols Research Group of the UK Health and Safety Executive.
In 2000, Dr. Maynard joined the National Institute for Occupational Safety and Health (NIOSH), part of the U.S. Centers for Disease Control and Prevention (CDC). At NIOSH, he established a groundbreaking research program in ultra-fine aerosol analysis, and was instrumental in developing NIOSH's nanotechnology research program. This research was at the forefront of international scientific efforts to better understand the occupational health implications of nanomaterials, and to develop guidance on workplace exposures in this burgeoning industry. While at NIOSH, Dr. Maynard was a member of the Nanomaterial Science, Engineering and Technology subcommittee of the National Science and Technology Council (NSET). He also co-chaired the Nanotechnology Health and Environment Implications (NEHI) working group of NSET. Both are a part of the National Nanotechnology Initiative (NNI), the federal research and development program established to coordinate the U.S. Government's annual $1 billion investment in nanoscale science, engineering, and technology.
Dr. Maynard was Co-Chair of the first two international conferences on nanotechnology and occupational health, and is affiliated with many organizations and initiatives exploring the responsible and sustainable development of nanotechnology. He is a member of the Executive Committee of the International Council On Nanotechnology (ICON), and until recently, chaired the International Standards Organization Working Group on size selective sampling in the workplace. He holds an Associate Professorship at the University of Cincinnati (OH), and is an Honorary Senior Lecturer at the University of Aberdeen (UK). His expertise covers many facets of scientific research and policy, from occupational aerosol sampler design to recommendations on strategic nanotechnology research, as reflected in over 70 professional publications. Dr. Maynard is a regular international speaker on nanotechnology, and frequently appears in print and on radio and television.
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Chairman BOEHLERT. Thank you very much, Dr. Maynard.
Mr. Nordan.
STATEMENT OF MR. MATTHEW M. NORDAN, PRESIDENT, DIRECTOR OF RESEARCH, LUX RESEARCH, INC.
Mr. NORDAN. Good morning, Chairman Boehlert, Ranking Member Gordon, and Members of the Committee, and thank you for inviting me to speak today.
My company, Lux Research, conducts hundreds of interviews and advisory sessions each year with companies that are commercializing nanotechnology. In this testimony, I will attempt to synthesize their views.
Ten months ago, this committee held its first hearing on nanotech EHS risks, and since then, commercialization has shot forward, and academic research on nanoparticle toxicity has broadened. However, when it comes to coordinate government action to address risk, very little has changed, and the status quo remains inadequate.
From the perspective of industry, nanotechnology EHS concerns fall into three categories: real risks, perceptual risks, and regulatory risks. Real risks represent the possibility that nanoparticles may harm workers or consumers or the environment. Although new publications in the last year have somewhat revised judgments about real risks, research is still extremely thin on the ground. Only about one-half of one percent of the 81,000 journal articles on toxicology since 2000 so much as mention nanomaterials.
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The second concern, perceptual risks, is the threat that even if nanoparticles were shown to be entirely benign, public skepticism could still make their commercial use untenable. In the United States, consumer perceptions of nanotech remain unchanged. Citizens remain uninformed but favorably predisposed. What has changed is the aggressiveness of non-governmental organizations that are hostile to nanotech, particularly outside the United States. When the French government's Ninetech nanotechnology research center opened in May, protesters stormed conference rooms and accosted scientists on the street.
The final concern seen by industry is regulatory risks, worry that the playing field will shift underneath them. Now this concern isn't what you might expect. Corporate EHS officers consistently want to see regulation that will help them plan, yet regulatory ambiguity persists. While companies are pleased about how the EPA, in particular, has communicated with them, they are also frustrated by how slow the EPA has been to set specific guidance, namely its long-proposed voluntary stewardship program for nanomaterials.
These three concerns, real risks, perceptual risks, and regulatory ambiguity, are adversely impacting nanotech commercialization in the United States. A few large corporations are halting nanotech activities entirely. One Fortune 500 R&D head told us that, ''Our CEO decided to postpone new investments in nanotechnology until the FDA decides how it will be handled.''
Venture capitalists are beginning to shrink from funding start-ups that face nanotech EHS risks, as prominent nanotech investor Steve Gervitson recently stated. Firms are increasingly banning references to the word ''nanotechnology'' because of perceptual risks, even as they pursue nanotech R&D, a dangerous approach that risks a backlash. Estée Lauder, for example, reportedly held a special meeting earlier this year, instructing employees never to use the ''nana'' prefix.
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Finally, start-ups even struggle to obtain business services. We have heard direct reports of one U.S. insurer cancelling coverage of small companies once it learned that they were involved with nanotech.
This committee has asked what the priority areas of research should be. We don't see identification of priority areas as being the key roadblock to progress. Multiple well developed needs lists have already been produced by organizations ranging from the EPA to the Wilson Center and, most recently, NEHI. They all prioritize the development of test methods, hazard screening, and exposure route investigation.
What is missing is not this ingredients list, but two things: a specific game plan for accomplishing the research, and adequate funding to execute it.
The biggest issue is the absence of a game plan. Nanotechnology EHS research in government agencies, academic institutions, and industrial facilities is being performed in an ad hoc fashion, according to individual priorities. The NEHI Working Group has not yet established a research strategy, one that makes tough decisions about prioritizing specific research tasks, apportioning them to public and private sector entities, and measuring progress.
Now this is not surprising, because NEHI has no authority to mandate such priorities, and it can't allocate funding. A new interagency body with such authority is required to break the deadlock. We believe the effort to establish one and formalize a clear, short-term research plan should be led by the National Academy's Board of Environmental Studies in Toxicology and the National Institute of Environmental and Health Sciences.
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The second issue is funding. We continue to believe that the appropriate funding level for these risks is likely between $100 million and $200 million annually, or two to four times today's spending. This is not an arbitrary figure. It represents a consensus widely held in industry and among non-governmental organizations formed by bottom-up calculation, analogy to other materials, and calculations that figure the costs as an insurance premium for nanotech.
Nanotech continues to move forward rapidly in the United States. Just in the last three months, free scale semiconductors shipped pioneering nano-enabled memory chips. Becton-Dickinson partnered to create new nano-enabled diagnostics that will revolutionize disease testing.
The United States has faced new EHS issues from previous broad technology waves, like semiconductors and polymers, in the past and addressed them effectively. The same can be done in nanotech.
Thank you for inviting me to speak, and I am pleased to answer any questions.
[The prepared statement of Mr. Nordan follows:]
PREPARED STATEMENT OF MATTHEW M. NORDAN
Global sales of products incorporating nanotechnology are more than doubling annually, but environmental, health, and safety (EHS) risks threaten to stall commercialization. Industry sees three key concerns: Real risks, perceptual risks, and regulatory risks. Awareness among the scientific community is already in place and multiple, well-developed lists of research needs are already built. Now, the Federal Government must establish a game plan for basic research—which will require a new interagency body with the authority to implement that plan—and supply adequate funding to carry it out. These actions will enable companies to carry out their own research on specific applications, and help address perceptual and regulatory risks in the bargain.
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Nanotech EHS Issues Still Confront Industry
Since the House Committee on Science last held hearings about the environmental, health, and safety (EHS) risks of nanotechnology in November 2005, the debate about whether and how nanoparticles might injure workers, harm consumers, or damage the environment has intensified.(see footnote 40) Nanotech's growing commercial success—$32 billion in products incorporating nanotech were sold in 2005—has meant increased scrutiny of EHS issues from advocacy groups and regulators, and increased urgency among companies developing products that incorporate nanoparticles (see Figure 1).(see footnote 41) Lux Research studies the commercialization of nanotechnology and advises companies about how they should approach nanotech opportunities, and when it comes to EHS issues, we see three key concerns faced by industry (see Figure 2):(see footnote 42)
Real risks of nanoparticles. Companies working with nanoparticles—like metal nanopowders, carbon nanotubes, and quantum dots—need to ensure that their materials and applications won't harm people or the environment. But considerable uncertainty surrounds real risk because the hazards of most nanoparticles are not well understood, exposure can be difficult to predict and measure, and even solid scientific studies arrive at contradictory results. For example, researchers at Rice University's Center for Biological and Environmental Nanotechnology found that even at low concentrations, fullerenes are toxic to bacteria and human cells in water; however, others at the Université Paris XI found the same particles not only safe but beneficial, protecting lab rats' livers from damage caused by other chemicals.(see footnote 43) While scientists debate, companies like General Electric must forge ahead now with decisions about how to invest in nanotech R&D, partnerships, and products.
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Perceptual risks when real dangers are unknown or misunderstood. Regardless of the real risks presented by any given nanoparticle or application, firms developing products using nanoparticles could find commercial feasibility blocked by the perception that the materials are dangerous—even if they are proven safe. Public perception of nanotechnology in the U.S. remains largely undetermined to date, with public opinion surveys continuing to show low awareness of nanotechnology and high optimism. A 2005 U.S. study found that just 16 percent of respondents rated themselves ''at least somewhat informed'' about nanotech, but in the same study 66 percent agreed with positive statements about the field.(see footnote 44)
However, many non-governmental organizations opposed to nanotech development—particularly those overseas—have grown more forceful in their protests. In May 2006, the environmental group Friends of the Earth issued a fiery report on the use of nanoparticles in cosmetics and sunscreens, condemning companies for ''treating their customers like guinea pigs'' and calling for a ban on the use of nanomaterials in these products. When the French government's Minatec nanotechnology research center opened in May 2006, protestors stormed conference rooms and accosted scientists on the street. Such reactions make firms like Johnson & Johnson look at the decades-long public relations and legal battles over supposedly dangerous products, from silicone breast implants to red M&Ms, and wonder whether even the safest nanoparticles could become a liability.
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Regulations—or lack thereof. U.S. companies will also have to abide by regulations of nano-enabled products and processes, ranging from workplace guidelines under the Occupational Health and Safety Administration to restrictions on the release of materials by the Environmental Protection Agency (EPA)—as well as regulations in the other countries where they do business.
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The EPA held a public meeting in June 2005 to solicit comments on a proposed voluntary pilot program that would collect data on nanomaterials. In December it issued a regulatory decision on carbon nanotubes, the first nanoparticle submitted to it under the Toxic Substances Control Act, approving the material for manufacturing under a low release and exposure exemption; the EPA also issued a broad draft white paper on nanotechnology in the same month. Meanwhile, the Food and Drug Administration (FDA), National Institute for Occupational Safety and Health, and Consumer Product Safety Commission have all issued position papers on nanotechnology. The FDA has also gone further, announcing the formation of an internal task force and calling public meetings on nanotech.
Despite all the action, regulatory ambiguity persists—it's still often not clear how current regulations apply to nanoparticles or whether and when agencies will issue new ones—leaving firms that work with nanoparticles confused about how to plan for regulatory rulings. While companies are generally pleased about how the EPA, for example, has communicated with them so far, they're also frustrated by how slow those agencies have been to set specific guidance, like the EPA's long-proposed voluntary Stewardship Program for nanoparticles.
With nanotech continuing to shift more and more from ''R'' to ''D'' and into products—$150 billion worth of nano-enabled products will be sold by 2008—sound policy to help firms manage these risks effectively is more urgent than ever.
EHS Risks Are a Gating Factor for U.S. Nanotechnology Leadership
Our firm conducts hundreds of interviews, site visits, and advisory sessions each year with executives and scientists responsible for nanotech at large corporations, as well as leaders of startups specializing in nanotech. Our conversations with them rarely fail to touch on EHS issues. We hear that even as many U.S. corporations and start-ups drive nanotech commercialization forward, others are canceling their efforts or failing to find funding and support for them due to EHS risks.
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The sheer cost of real risk dissuades companies from worthy endeavors. Without the data, tools, and frameworks needed to manage the real risks of nanoparticles, large corporations retrench rather than expose themselves to undue liability or sink millions into toxicity tests. Meanwhile, nanotech start-ups face an even tougher situation—they have little hope of funding such research on their own, yet their customers expect them, like any other supplier, to come equipped with data on health effects. Interviewees consistently cite nanoparticle EHS concerns as a major topic of discussion, and even a bargaining chip, in partnership negotiations.
''We've stopped development where costs were too high to ensure no exposure or risk across the life cycle, or where we couldn't clearly judge hazard potential due to the lack of accepted methods. It's quite complicated; we can't set decision points today.'' (Corporation)
''The BASFs, Degussas, and DuPonts of the world come in with their act together, but start-ups typically say, 'Oh, we didn't bring the EHS guy with us.' We've canceled several projects because of a lack of EHS information from the supplier. We could generate the information ourselves, but it's just not worth it.'' (Corporation)
Perceptual risks threaten to drive ''nano'' underground. Companies are universally concerned about perceptual risks but don't know how to handle them, and many try to duck the issue by simply forbidding the term ''nanotechnology''—a dangerous strategy that risks a backlash. Executives at Estée Lauder reportedly held a special meeting in early 2006 to instruct employees, brand managers, and customer relations people to cease any use of or reference to the term. Solar-cell maker Konarka takes pains never to mention the fullerenes it uses in its flexible photovoltaics, lest EHS fears about fullerenes damage the ''clean and green'' message it emphasizes to investors and the public. Even companies that are comfortable with the real risks of their materials don't trust their buyers to make informed decisions about them:
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''We promote the benefits better products bring without talking about technology. With nanotech, it's no different: You won't hear us talking about nanotech or advertising it in any way. That's our strategy for dealing with potential negative publicity.'' (Corporation)
''Our strategy is pretty clear. Focus on features and benefits; give the products names associated with benefit of product; don't put 'nano' in the name of the product.'' (Start-up)
Corporations are eager for regulation; among start-ups, paranoia reigns. Contrary to what one might expect, large corporations consistently want to see clear regulatory guidance on nanoparticles, which they feel will ensure a level playing field and tell them what to plan for. These firms are enthusiastic about the EPA's approach—which lets them participate in its deliberations and gain insight into its thought processes—but frustrated by agencies like the FDA that have communicated less on key issues. With start-ups, on the other hand, we frequently hear the plea for ''rational'' and ''science-based'' regulations—subtext for fears that regulators will overreach and impose sweeping and onerous rules that could kill their businesses.
''Our CEO decided it was too early to make any more investments in nanotech until the FDA makes some decisions on how it will be handled. We're all very disappointed about this, since we have already dedicated significant resources.'' (Corporation)
''For some of our product categories, a full battery of tests might cost $40 million. But if it's a reformulation of an existing compound, it could be only a few hundred thousand. Right now with nano we have no idea which it will be.''(Corporation)
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''We're working very hard to make sure regulations are in place. Everyone benefits from strong, robust regulations—not only to protect consumers, but to level the playing field for companies, so that everyone puts the right amount of thought into protecting health and assessing safety.'' (Corporation)
''I'm concerned about the regulatory environment. We need (real risk data), or we'll get regulated to levels that don't make sense in terms of facts. Our concern is that regulations will change not based on fact, but based on hysteria. . .hopefully the regulators won't do something silly.'' (Start-up)
''I have no idea how (regulation) is going to evolve. It could be very factual and science-based, or it could be very politicized. We'd like to influence it and have it be rational.'' (Start-up)
The combination of the struggles firms face around all three factors is leading to adverse consequences for industry and the U.S. economy, as promising innovations get de-prioritized in corporate R&D budgets for reasons unrelated to performance, price, and market demand. The results can be particularly dire for the small firms that our technologically-driven economy relies on to develop crucial innovations. Venture capitalists are beginning to shrink from funding start-ups that face nanotech EHS risks, as prominent U.S. nanotech investor Steve Jurvetson stated in a recent Nature article.(see footnote 45) Start-ups even struggle to obtain business services: At least one U.S. insurer has canceled coverage of small companies once it learned they were involved with nanotech.
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Government Support for Basic Research Will Help Address Real Risks
Clearly the first and most important responsibility of any company developing nanoparticle applications is to ensure that they won't present hazard to workers, consumers, or the environment. As we have described previously, conventional risk management paradigms—identifying hazard, characterizing hazard, assessing exposure, and characterizing risk—can be applied to nanoparticles, and only applications where both hazard and exposure are present constitute serious risks.(see footnote 46) However, many aspects of nanoparticles make them uniquely challenging to address (see Figure 3). These challenges boil down to two key categories of research needs:
1) Lack of specific data. Simply put, the health and environmental effects of nanoparticles haven't been studied well enough for EHS professionals to assess them confidently. While a vast literature on conventional materials exists for these researchers to draw on, the literature on nanoparticles still lags behind by a wide margin. A scientist working with an organic chemical can very likely turn to the literature and find several papers addressing the health effects the compound she is studying, or at least very similar ones; scientists working with nanoparticles have no such luxury. Of 81,334 peer-reviewed journal articles on toxicology from January 2000 through May 2006, just 0.6 percent make any mention of nanoparticles—compared with 12 percent for polymers, a much better-known class of materials.(see footnote 47) More specifically, we identified just 316 articles specifically focused on the EHS risks of engineered nanoparticles (through May 2006) from a review of over 1,500 documents drawn from databases of published research like that maintained by the International Council on Nanotechnology (ICON) at Rice University, literature searches using Science Citation Index; and review articles like the report from the International Life Sciences Institute Nanomaterial Toxicity Screening Working Group.(see footnote 48)
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2) Lack of well-developed frameworks for understanding real risks. For more familiar classes of chemicals and materials, long experience has given scientists a good understanding of what characteristics make a substance harmful, so they can make reasonable judgments even when they lack specific toxicity data. In the case of nanoparticles, however, these frameworks (often referred to as ''structure-activity relationships'') are only beginning to be developed, and current results often contradict each other. For instance, while Günter OberdoAE4rster at Rochester University found that smaller particles of titanium dioxide (TiO) are more harmful that large ones, David Warheit at DuPont found no relationship between size and toxicity; he also found that nanoparticles of silica (SiO) and zinc oxide (ZnO) are less harmful than larger ones.(see footnote 49)
Nanotech's critics rightly point out that companies themselves must take responsibility for generating data on the specific materials they work with and applications they put the materials to, and shouldn't depend on the government to do it for them. This important point addresses the first category of research need above.(see footnote 50) However, the key role for government lies in the second category of research need: Supporting the basic research needed to develop frameworks that companies and researchers can put to use in evaluating their own materials. Just as wise government funding produced the fundamental scientific breakthroughs that lead to the successful nanotech commercialization we're seeing today, similar investment in understanding the basic science of nanoparticle EHS factors will underlie safe nanotech developments.
Research Priorities Are Well-Understood; What's Needed Is a Game Plan and Money
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In terms of specific research needs, we do not see identification of priority areas of research as being the key roadblock to progress. Multiple well-developed needs lists have already been produced by organizations ranging from the EPA to the Wilson Center, and they all prioritize the development of test methods, hazard screening, and exposure route investigation (see Figure 4). What is missing is not this ''ingredients list,'' but two things: A specific game plan for accomplishing the research and adequate funding to execute it.
A new interagency body must form a nanotech EHS game plan—with authority to execute. The biggest issue is the absence of a game plan; nanotechnology EHS research in government agencies, academic institutions, and industrial facilities is expanding, but it is being performed in an ad hoc fashion according to individual priorities that both risk costly duplication of effort and raise the specter of key issues remaining unaddressed. The National Science and Technology Council's Nanotechnology Environmental and Health Implications working group (NEHI), the body nominally in charge of nanotech EHS issues as part of the National Nanotechnology Initiative (NNI), has not yet established a research strategy—one that makes the tough decisions about prioritizing specific research tasks, apportioning them to public and private sector entities, and measuring progress. This is not surprising, because NEHI has no authority to mandate such priorities and cannot allocate funding. A new, interagency body with such authority is required to break the deadlock. The effort to establish such an authority and formalize a clear, short-term research plan could be led by NEHI, but also the National Academies' Board on Environmental Studies and Toxicology or the National Institute of Environmental Health Sciences.
Funding must grow. We continue to believe that the appropriate funding level for addressing nanotech EHS research needs is likely between $100 and $200 million annually, or two to four times today's spending under the NNI. This figure is not an arbitrary number, but represents a consensus widely held in industry and among non-governmental organizations formed by bottom-up calculations, analogy to other materials, and calculations that figure the costs as an ''insurance premium'' for nanotech development.
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Towards these ends, Lux Research has joined with a broad consortium of nanotech stakeholders, including leading corporations active in nanotech (like Air Products & Chemicals, BASF, Degussa, and DuPont), non-governmental organizations (like Environmental Defense, the Natural Resources Defense Council, and the Union of Concerned Scientists), prominent nanotech start-ups (like Altair Nanotechnologies and Carbon Nanotechnologies Inc.), and business associations (like the NanoBusiness Alliance). This coalition has petitioned the Senate Committee on Appropriations both to increase funding for nanotech EHS research, and to allocate $1 million to the National Institute of Environmental Health Sciences and the National Academy of Sciences to develop a specific game plan for the U.S. Government's approach to nanotech EHS research. We encourage Committee members to support these efforts.
Better Research on Real Risks Will Help Address Perceptual and Regulatory Ones
There is less that Congress can do to aid with perceptual risks, and while regulation clearly falls into the Federal Government's remit, key decisions need to be made at regulatory agencies. However, successfully addressing the basic research needs around real risks will help make significant progress on these challenges as well. Consider that:
Better understanding will drive regulation. Regulatory transparency is important for nanotech's commercial development, but agencies are hesitant to issue specific guidance, even on general principles, without a better scientific understanding of the issues involved. While we still think agencies can do more to communicate their thinking to industry and to set specific regulatory expectations in a timely fashion, the basic research spurred by additional investments and research prioritization alone will help them set firm plans.
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Lack of knowledge—and of regulations—are major drivers of perceptual risks. One of the most significant ''fright factors'' identified for new technologies is ''poor understanding by science or responsible agencies,'' which certainly describes nanotech today.(see footnote 51) Moreover, arguments that nanotech is unregulated are widely used by groups calling for restrictions on development. By addressing this lack of understanding and abetting regulatory efforts, Congress can help promote informed public understanding of nanotechnology's benefits and risks.
Addressing Nanotech EHS Risks Has a Big Economic Payoff
Nanotechnology continues to move forward rapidly in the U.S.—just in the last three months, Freescale Semiconductor has shipped pioneering nano-enabled memory chips, and Becton Dickinson has partnered to develop new nano-enabled medical diagnostics that could revolutionize disease testing. While we calculate that $32 billion in nano-enabled products were sold in 2005 and project that $150 billion will be in 2008, and that by the middle of the next decade this value will figure in the trillions of dollars globally. The U.S. has faced new EHS issues from previous broad technology waves, like semiconductors and polymers, in the past, and addressed them effectively; it's important that we do so for nanotechnology as well—since the challenges facings our country in achieving energy independence, finding curing for debilitating diseases, securing the homeland, and creating new jobs and economic growth all benefit from nanoscale science and engineering.
BIOGRAPHY FOR MATTHEW M. NORDAN
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Matthew Nordan is the President of Lux Research and heads the company's research organization. Under Matthew's leadership, the Lux Research analyst team has become a globally recognized authority on the business and economic impact of nanotechnology. Lux Research serves as an indispensable advisor to corporations, start-ups, financial institutions, and governments seeking to exploit emerging technologies for competitive advantage.
Matthew has counseled decision-makers on new technologies for a decade. Prior to Lux Research, Matthew held a variety of senior management positions at emerging technology advisor Forrester Research, where he most recently headed the firm's North American consulting line of business. Earlier, Matthew lived for four years in the Netherlands growing Forrester's operations in Europe, where he launched and led research practices in retail, mobile commerce, and telecommunications.
Matthew has been invited by news outlets including CNN and CNBC to comment on emerging technology markets and has been widely cited in publications such as The Wall Street Journal and The Economist. He has delivered advice to clients and been an invited speaker at conferences in North America, Europe, Southeast Asia, Japan, Australia, and South Africa. Beyond the corporate sphere, Matthew has testified before the U.S. Congress twice on nanotechnology issues, advised the Committee to Review the National Nanotechnology Initiative of the National Academies, and spoken on nanotechnology at universities including Harvard, MIT, and Columbia. Matthew has also participated in developing public-sector technology strategy for organizations including the World Economic Forum, the European IT Observatory, and the Dutch transportation ministry.
Matthew is a summa cum laude graduate of Yale University, where he conducted cognitive neuroscience research on the neural pathways mediating emotion and memory.
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Discussion
Coordinating Federal Environmental, Health, and Safety Nanotechnology Research Programs
Chairman BOEHLERT. Thank you very much, Mr. Nordan.
I would point out to the government witnesses that both you and Dr. Maynard have pretty clearly and convincingly laid out the deficiencies in the current federal program. And quite honestly, if I sense things up here from this side of the witness table, I think Mr. Gordon, in his opening statement, which was very emphatic and very eloquent, he has got the mood of the Committee on both sides of the dais.
So here is what I would like to do. I would like to ask each of our witnesses what they think needs to be done to have a truly coordinated, targeted, prioritized federal program. And while you are giving some thought to that, let me point out that what—you have been at this for more than a year, and what, essentially, we have is a basic inventory. We don't have any priorities. We tell that is the ''next step.'' I mean, I think we should be a lot farther ahead now than we are. I was a little—tried to finesse it a little bit in my opening statement, but Mr. Gordon got right to it. And I have to say, ''Amen.''
So let us go. You are the——
Mr. GORDON. Mr. Chairman, if I could, I think you have hit the heart of the question, and I would like to share my time with you, if these folks need the time to address, again, the fundamental question for us today.
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Chairman BOEHLERT. Yeah. And so let me just repeat it.
What do you think needs to be done to have a truly coordinated, targeted, prioritized federal program?
Dr. Alderson.
Dr. ALDERSON. Thank you, Mr. Chairman.
Obviously, this is a very important question to the NEHI group and NSET as well.
My response to your question is, and I think I am speaking for all the members of the NEHI committee, we believe we are on the track to get to that point. The issue is how long will it take us to get there. All of the 19 agencies that are represented on NEHI represent the best scientists, expertise, I think, the Federal Government has to offer on this issue. Bringing them together in this environment, I believe, is the best approach to get there.
How to speed that up is another issue.
As you mentioned earlier, all of us have other jobs. This is something else we are all doing. So it is a matter of how much time do you want us to spend on this, how much does our respective agencies want us to spend on this to make this happen. But I really, honestly believe this group is the body to do that.
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Chairman BOEHLERT. Dr. Bement, look, you are right. Just let me point out that once again, as I said before, we have a high regard for each one of you. You are dedicated, very able federal employees. I don't know how many various interagency panels you are on, Dr. Alderson, for example, and Dr. Bement. I mean, it is probably as long as—the list is as long as your arm. Some—we would be comforted if we had some indication that you are giving some priority attention to this. And I understand all of your other demands in your schedule, but there is no evidence of that thus far. I would suggest that the one reason we have this report today is we sort of forced it, because we have scheduled this hearing, and your staff probably said, ''We have got to get ready for those guys. They are going to ask some questions. You better show some movement.'' So this is what you came up with. And if this hearing hadn't been scheduled, we probably wouldn't have anything yet.
So I am not trying to be argumentative or confrontational. I just want you to sense from here that we feel very strongly about this on both sides, and we know you have the wherewithal, the commitment, and all of that. Let us hope you get some time and attention to it.
Dr. Bement.
Dr. BEMENT. Well, I will address your question from my perspective.
Chairman BOEHLERT. Yeah. And well, while you are at it, I wanted to ask, is there someone that you think should be directed to have his sole job as being chair of this coordinating agency?
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Dr. BEMENT. Well, I will come to that question in a moment.
The first point I would like to make is that characterizing the current situation as a ''bottom-up approach'' is overstating it. It is true that it is bottom up as far as science input and the various agencies' input into the budget formulation process. But it is also lateral. There is a lot of interagency cooperation. We solicit inputs from the regulatory agencies in identifying those scientific questions that we need to address. And it is also top-down through the budget——
Chairman BOEHLERT. Well, that is very important. You know. And the top-down—what I am asking is should we get someone solely committed to coordinating this thing, or do we say to Dr. Alderson——
Dr. BEMENT. Well——
Chairman BOEHLERT.—this is the 27th item on your agenda. You have got to chair this interagency——
Dr. BEMENT. Okay. I have been in government a long time, and almost in every new program of this type, everyone wants this on top, but I have to tell you that this area is so complex that I don't know of any person or a small group of people who would be smart enough to be able to identify all of the risks, set the priorities, and lay out a so-called game plan. That has to be very organic, and it is organic. It—the situation changes day by day. And so there has to be more of a soccer approach to this rather than an American football approach, if I can put it in that metaphor.
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Chairman BOEHLERT. Dr. Maynard is nodding yes.
Mr. GORDON. The Chairman graciously—we are sharing time and sharing this. We are not asking that there be somebody smart enough that knows it all. We are asking that there is somebody that is able to coordinate it all. I think there is a difference.
Dr. BEMENT. Yeah. Well, I didn't say the last thing I wanted to say, and that is how it is top-down managed. It is top-down managed through the budget—the formulation of the budget review and the budget approval process in putting together the Administration's budget to the Congress. That is a matter of policy. It is policy formulation. And that is a very well coordinated process through OMB and OSTP. So you do have two very high government offices that do provide this coordination, and it is top-down.
Mr. GORDON. So you are satisfied that we have got the best plan now or the best——
Dr. BEMENT. No, I am not satisfied. I came up through nuclear technology, and I know what happened to that industry because it wasn't visible enough. It didn't have adequate dialogue with the public at large. And they weren't forward with—they weren't as forthright as the industry needed to be about risks. We have to avoid that, and we have to be anticipatory. We have got to be proactive, and we need to turn up the gain. I have no arguments with any of that.
Chairman BOEHLERT. Yeah, but you are not satisfied with the present arrangement. I mean, won't you concede to us? I mean, I am not trying to put you in a spot, but you can't be happy with where we are right now, given the magnitude of the problem and the magnitude of the challenge.
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But I—once again, Doctor, I can imagine what your schedule is like every single day, each one of you in the government. You have got more things to do than you have got time to do them. But we are suggesting that maybe someone should be, not a Czar, but at least a coordinator and have more time to devote to coordinating. I mean, how do your various departments decide how much to allocate to nanoresearch? Does OMB tell you how much you allocate? I mean, he doesn't know diddley about nanoresearch. Is it just an exercise in numbers?
Dr. BEMENT. Well, I think each agency has a process for developing priorities and also developing their request. And that has to be discussed, and it has to be prioritized. And that is, again, OMB and OSTP.
Chairman BOEHLERT. Well, let us get Dr. Farland a chance to answer the question.
Dr. FARLAND. Thank you, Mr. Chairman.
Chairman BOEHLERT. And keep in mind you have already announced that you are already retiring, so you can be a little bolder if you want to.
Dr. FARLAND. Well, I am just going to start my remarks by suggesting that both society and government really have multiple needs in understanding these health and environmental issues. And so I think to suggest that there could be a single approach that was really going to get to this without addressing those multiple needs may be a bit naive. So I think we have to look at this from the standpoint of the complexity of the problem that we are facing.
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Chairman BOEHLERT. But, Dr. Farland, let me just say, first of all, I am not a scientist, and Mr. Gordon is not a scientist. We have got some scientists, a couple of physicists on the panel, and Ralph Hall knows everything about everything. But—so we are not suggesting that it is easy. What we are saying in every way that we know how is that we think it should be given a higher priority. There should be better coordination. We think we should be farther ahead than we are now after a more than a year invested, the time and talent of several able, dedicated public officials. And what we have now is just sort of a basic inventory that was sort of forced out, you know, pulled out, extracted because the hearing was scheduled. So——
Dr. FARLAND. Well, let me try to address a few of those points, because I think that, first of all, from an agency perspective, we benefit tremendously by the kind of interagency dialogue that has gone on in the NNI and in the NEHI particularly. We play a large role in that. We share the feelings we have about the priorities. We take from others what they can do and what their priorities are.
We also take that back, and we don't wait for those priorities in terms of making decisions.
Mr. GORDON. Okay. If I could—are you satisfied with the structure, as Dr. Alderson said, to get us—he used the word ''there.'' I would like to know more what ''there'' is. But are you satisfied that we have an adequate structure to get us ''there''?
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Dr. FARLAND. I think we have a structure that is working very well right now. It has a way to go. I agree with that. I agree that we have——
Mr. GORDON. Okay. So how do we—you know, so what else do we need to do? To me, that is the fundamental question here we are trying to determine is whether or not we have a structure that is going to allow us to get, as Dr. Alderson said, you know, ''there.'' And we can talk about ''there'' other—I mean, but do we have that structure? And if not, how do we need to—it is not a criticism to anyone. You know.
Dr. FARLAND. Dr. Bement talked about the idea of turning up the game. And I think that is happening. It is happening as we work through these kinds of issues. It is happening as we have our dialogue, our workshops with our——
Mr. GORDON. So we have an adequate structure? There just needs to be more intensity within that structure? Is that——
Dr. FARLAND. That is the way I see it.
Mr. GORDON.—what you are—okay. All right. Thank you.
Chairman BOEHLERT. Dr. Carim.
Dr. CARIM. Yes. Thank you.
With respect to the report, honestly, we have done our best to produce a report that tries to address these issues in a way that is coordinated across the Federal Government, the federal agencies, and that is of high quality, that really produces a science-based approach to risk assessment and to what the research needs are in this area. And that takes time. It has been an ongoing effort, and I think the level of effort has been quite high. And I won't deny the fact that certainly the presence of the upcoming hearing and the activities——
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Mr. GORDON. And so are you satisfied with the——
Dr. CARIM.—have added some——
Mr. GORDON.—structure that we have?
Dr. CARIM. Yes, I am.
Mr. GORDON. Okay.
Dr. CARIM. I think——
Mr. GORDON. All right. That is fine.
Dr. CARIM. I think that having these other activities certainly added some urgency to agency responses and to agency approvals, and that is a good thing.
I would agree with the comments of my colleagues, and I do think that, with respect to a more top-down organization, you have heard some things about the top-down aspects that are already in place, but I share the Chairman's sentiment that diversity is a source of strength in the research programs of the United States. And this is already one of the most highly coordinated activities across agencies, and I am afraid that taking too much of a top-down approach will cause us to miss things. That is one of my largest concerns is that if we feel that we have identified the priority areas and addressing those——
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Mr. GORDON. Could they help us be more efficient with what seems to be terribly limited funds?
Dr. CARIM. I am sorry?
Mr. GORDON. Could it help us to be more efficient with what seems to be terribly limited funds?
Dr. CARIM. Increases in efficiency are always valuable. The question is how to do that. And I think it is all of the agencies.
Mr. GORDON. Okay. But we wouldn't have as much duplication, potentially, if we had more leadership?
Dr. CARIM. I don't believe that we have much duplication.
Mr. GORDON. Okay.
Dr. CARIM. I believe that the——
Mr. GORDON. All right.
Dr. CARIM.—interagency coordination process is very effective in informing each agency as—of what the others are doing.
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Chairman BOEHLERT. Thank you, Doctor.
I am anxious to get to other members of the panel. We shared this opening time, and I hope this is instructive to all of you that there is a high level of intensity in terms of our feeling on this. And before I call on Dr. Schwarz, I don't know—Dr. Maynard and Mr. Nordan are the ones that outlined the problem, so we needed the government agency to—I mean, they agree with you and with us, essentially.
It is unfortunate that somewhere someone mentioned the word ''czar,'' because then we—it connotes a dictator is going to say, ''This is what you are going to do.'' And that is not what we are talking about. We are talking—when we talk about someone at the top, just devotes more time and more effort to do a better job of coordinating the diverse elements coming in and helping to get what Dr. Maynard and Mr. Nordan are pleading for, some priorities and some emphasis. So we are not talking about a dictator that we want to install someplace in Washington, DC, but we are saying that we want—and I hope it is instructed for all of you, we want something more than what we have now. We are not satisfied. We are not pointing fingers at any one individual saying, ''You are not doing your job.'' We are just saying the present mechanism doesn't seem to be working in a way that would satisfy us that we are giving a sense of sufficient urgency to the issue.
With that, let me call on Dr. Schwarz.
Regulatory Structure for University and Industry Nanomaterial Research
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Mr. SCHWARZ. Thank you, Mr. Chairman.
I am randomly asking, so anyone jump in that chooses to do so.
I am a cutting doctor and not a research doctor. However, I am on the board of the Life Science Institute at the University of Michigan, which meets tomorrow, in fact, on the board of the Cardiovascular Center at the University of Michigan, on the Deans Advisory Committee for the school at that university, which supervises those activities, and I am the President of the Alumni Association of the University of Michigan, which I think all of you would say is one of the foremost research universities in the country. So I have an interest in this.
Very, very briefly, many of the new therapies, the 21st century therapies, putting an anti-cancer substance right on the tumor cells right in the affected organ, putting the material right at the correct spot in the correct coronary artery, et cetera. That is not Buck Rogers stuff anymore. That is stuff that can be done in the lab with nanomaterials. Yet there seems to be no regulatory structure right now that a place like my university or other universities—a structure that they can look to to say, ''This is what we can do and this is what we can't do.'' But my question is this: what do you foresee and when do you foresee a structure, an office, an organization at the federal level, or certainly overseen by the Federal Government, that a University of Michigan or a Harvard or a Yale or a Stanford or a Cal or a Kansas or a Nebraska can look to when they do this research and say, ''This has been vetted. This is okay. We can go ahead with animal research. We can even go ahead with, perhaps, clinical trials on humans.''? Who is going to be the referee here, and when is that referee going to be up and ready to make his or her calls?
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Dr. ALDERSON. Thank you, Mr. Schwarz, for that question, and I think it is an excellent one, because it brings into the forefront a very significant potential use of nanomaterials. And what you are talking about is a delivery mechanism to bring therapy to cancer patients, i.e. bringing that pharmaceutical directly to that tumor or that cancer site. We are, within FDA, having frequent conversations with companies and academic institutions on this particular issue. We believe we have the structure in place today to be able to communicate with those companies that are developing these products. We have a very structured process of determining the safety, particularly—as a major concern, particularly for the nanomaterials if it is something that is normally—that is foreign to our body. But we have—I think we have that structure in place today to talk to a company who is manufacturing that and guide them through the type of information we want to see along the process from the basic pharmaceutical information to laboratory information to determining whether it is safe enough to go to clinical trials. I think——
Mr. SCHWARZ. You——
Dr. ALDERSON. I think that we have that.
Mr. SCHWARZ. Dr. Alderson, you feel that you have guidelines in place that are reliable that legitimate researchers can pick up the phone, travel to Washington, you can have someone travel to their lab, and you have got standards in place that are reliable standards where a lab, whether it is in a university or in a private organization, can actually come to you and say, ''Is this good? Is this bad? Can I do this? Can I not do this?''
Dr. ALDERSON. We have guidances in place for that type of product, and we are regularly talking with companies along those same lines you are talking about. Now we may—down the road, we may find that something we are asking for presents an issue that we haven't seen before, and we will have to work with the company in a manner to overcome that particular issue.
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Mr. SCHWARZ. I am happy to hear that, because I—in my mind, I had assumed, always a dangerous thing, but I had assumed that there was—that the structure was a work-in-progress and there wasn't a good identifiable, reliable structure in place. You are telling me that there is?
Dr. ALDERSON. I think we are prepared to talk with any company who wants to talk to us about a product like that.
Mr. SCHWARZ. And any university as well?
Dr. ALDERSON. Anyone.
Mr. SCHWARZ. Thank you.
Chairman BOEHLERT. The gentleman's time has expired.
Here is the deal. There is a series of votes in the House, and we are not going to keep you here while we go over and play legislators. There will be a series of written questions that we will submit to all of you, and we would ask for timely responses.
In the time we have remaining, we are going to give a couple of minutes each, and we will run the clock down, to Mr. Green, and then is it Mr. Hall, Mr. Rohrabacher, and Mr. Honda. All right. Let us go.
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Mr. Green.
Is the Marketplace Outrunning Research?
Mr. GREEN. Yes, sir. Thank you, Mr. Chairman, and thank you and the Ranking Member for placing policy above politics. I will be as pithy and concise as possible.
It is my understanding, of course, that because something is nano doesn't mean that it is dangerous, per se. Nanomaterials can absorb pollutants in water. However, with hundreds of products on the market, $32 billion in revenue, by one estimate, an estimate that by 2014 we may have $2.6 trillion in revenues, and given that we are currently using—utilizing nanomaterials in clothing and cosmetics, the question has to become, first of all, is time on our side, given the way the marketplace is responding to this technology? And it has been said by someone that nanoparticles are like the roach motel: they check in, but they don't check out. So we have to ask ourselves about time and are we using our time as efficaciously as possible.
So to this end, I am curious as to whether we have any products right now that contain any kind of warning with reference to the use of nanoparticles?
Yes, sir, if you would. And be as quickly as you can, because I have another question.
Dr. MAYNARD. I will just briefly answer that.
I—you are exactly right. Not every nanomaterial is going to be safe. Not every nanomaterial is going to be harmful. We have got to find out what is the truth here. We have got to have sound science.
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Now if you look at what is on the marketplace at the moment, again, you are right: time is not on our side. We are having a flood of nano-based materials on the market, and I am not aware of any product which has any warnings or any identification of what any of the potential risks might be.
And while I am speaking, let me also say, going back to my statement, apparently I inadvertently credited the government with only spending $1 million a year on risk-based research. I apologize for that. The figure should have been $11 million a year.
Mr. GREEN. Quickly, one final question, if I may, Mr. Chairman.
We talked about warnings. Now what about notification? Is there a codified methodology by which notification can be perfected in the event we have some—well, some failure that we need to call to the public's attention in a massive way?
Mr. NORDAN. My understanding is that there is no such facility today. And I think if you look at the rare cases where there have been products that have incorporated nanoparticles or have been thought to incorporate nanoparticles where there have been health effects, it is a good demonstration. The best case study for this is a product by a company called Kleinmann in Germany called ''Magic Nano,'' which was a spray that was used as an adhesive in bathrooms that caused about 100 people to have respiratory problems and to check into hospitals. It was actually later found that the product contained no nanoparticles at all. But if you imagine, particularly from the perspective of someone like the——
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Mr. GREEN. Thank you, Mr. Chairman.
Chairman BOEHLERT. Mr. Honda.
And incidentally, we are trying to be mindful of your schedules. You know. You don't want to sit around and wait for us. And you are busy. We want you to go back to work on this in urgency.
Mr. Honda.
Setting Priorities
Mr. HONDA. Thank you. Thank you, Mr. Chair.
And I just—what I have surmised is that we have folks who say, ''This is adequate.'' And then we have this that tells us what is not adequate in this, and it sets up a timeline.
My question is have you read this document as of yet, Mr. Alderson—Dr. Alderson? The question is have you read this as of yet?
Dr. ALDERSON. Yes, sir, I have.
Mr. HONDA. And how do you see this fitting in this report?
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Dr. ALDERSON. They are both very consistent in terms of a focus of the research programs. Neither are that detailed in specific studies that I think we ultimately want to get to in terms of programs. The report you have in your hand there does give some areas in what should come first. And that may be correct. But I think the government, a little, has not done an assessment of that where it would either concur or not concur.
Mr. HONDA. How long would it take you to decide whether you need to take the first step or not?
Dr. ALDERSON. I could not give you an estimate of that, sir.
Mr. HONDA. Could you take a week and get back to me on this?
Dr. ALDERSON. Yes, sir.
Mr. HONDA. Thank you.
Chairman BOEHLERT. All set?
Mr. Lipinski.
Public Awareness of Nanotechnology
Mr. LIPINSKI. Thank you, Mr. Chairman.
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A lot of things to talk about here, but I will keep it very short. I would also want to make clear that I believe we need to move forward. We are not moving forward quickly enough.
And now moving forward to reading this report, I have not had a chance to read it yet, but it is critical, in this new technology, that we set the—what we need to let the people know, people have confidence in it, those in the general public and also those who are involved in nanotechnology know where we are going.
At another time, I would like to talk to Dr. Bement about what NSF is doing. I know NSF is doing a lot of funding of research in nanotech. At my alma mater, we have the center for nanofabrication and molecular self-assembly. I would like to talk to him at some other time if he thinks everything is going well with NSF funding for nanotech.
But what my question boils down to is does anyone on the panel have any opinions on a sense among the general public about—do you have any clue what nanotech is and the impact that it may have on them? And someone had raised earlier, when I was watching this, that the public needs to be comfortable with nanotech. Is this a problem that we have seen yet?
Dr. Maynard.
Dr. MAYNARD. Very briefly, earlier this week, we released the results of a poll of public opinions. This was a telephone poll of over 1,000 people across America, and we found some very interesting things. We found that there is still a low level of awareness of nanotechnology. Overall, it was about 30 percent of the people polled that heard something about it, although this figure is up from the previous poll two years ago by about twice the number of people. So people are beginning to get aware of this.
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People are also beginning to become aware of the debate over the benefits versus the risks. One of the messages not only in that but in also talking to people, we are finding that people want information of what is happening with this technology. They want to know where it is going to impact on their lives, what the benefits are, what the risks might be so that they can plan accordingly. At the moment, people are pretty ambivalent about whether it is good or bad. They want information.
Mr. LIPINSKI. Dr. Bement, do you have something you want to add?
Chairman BOEHLERT. And you will have the final word.
Dr. BEMENT. I will have the final word.
NSF is one of the promoters of nanotechnology. Also recognize at the very beginning of the National Nanotechnology Initiative, that it was critically important not only to look at the environmental and health safety aspects but also public outreach and education. And so we have a balanced program in that regard. But we started out with a huge agenda in this area. First of all, we had to do the basic research, and if I can take a little bit out of Dr. Maynard's written testimony, he calls for systematic scientific research to recognize potential risks at an early stage. He recognizes that nanotechnology is complex. And we have to look longer-term to identify emerging risks.
But in addition to that, we had to put an infrastructure in place. We even had to develop characterization tools so that you could even look at nanoparticles and understand it in terms of their size, their shape, their surface charge, their physical and chemical characteristics of nanoparticles, and not all of those tools are yet developed.
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Furthermore, and finally, we had to develop a workforce, a science and engineering workforce that not only could do the research but could also look at toxicology, could look at interaction with cells, could look at the various transport modes, and that workforce is now migrating into academia, in the National Laboratories, and also in the federal laboratories.
Chairman BOEHLERT. Thank you, Doctor.
That is it.
We have got less than five minutes to report, and we are considerate of your time, and so we could say we recess, but we are going to adjourn and—with this request: we will submit questions in writing, and we would appreciate a timely response. A timely response. And I would indicate that you get back before Dr. Farland and I go off into the sunset. The last time we submitted written questions, it took four and one-half months for the Administration to get the okay to get us answers. That is not ''timely response.'' So I am anxious to pursue this before I leave.
And secondly, Mr. Gordon rightfully points out that at the conclusion of the report, you talk about the ''next steps.'' Dr. Alderson, do you have sort of a timetable in mind for the ''next steps''? And keep in mind——
Dr. ALDERSON. Well, I think—Mr. Chairman, I think your message is loud and clear.
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Chairman BOEHLERT. Thank you.
All right. With that, adjourned.
[Whereupon, at 11:30 a.m., the Committee was adjourned.]
Appendix 1:
Answers to Post-Hearing Questions
ANSWERS TO POST-HEARING QUESTIONS
Responses by Norris E. Alderson, Chair, Nanotechnology, Environmental, and Health Implications Working Group; Associate Commissioner for Science, Food and Drug Administration
Questions submitted by Chairman Sherwood L. Boehlert
Q1. The Nanotechnology Environment and Health Implications (NEHI) working group report released on September 21, 2006 says that NEHI's next steps include assessing the existing portfolio of research on environmental and safety impacts of nanotechnology, identifying gaps, and setting research priorities. When will these activities begin and when do you expect them to be completed?
A1. The Nanotechnology Environmental and Health Implications Working Group (NEHI) will begin work immediately to address the ''next steps'' identified in the ''Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials'' (EHS) report. NEHI is comprised of representatives from the sixteen Federal Government agencies that are the most experienced and scientifically qualified in the U.S. Government to consider nanotechnology issues. They all recognize the importance of completing this effort as part of the United States' commitment to realizing the benefits of nanotechnology in a manner that is responsible and that protects health and the environment.
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An important next step is development of a more detailed inventory of the research currently being conducted by the National Nanotechnology Initiative (NNI) funded agencies. This will involve working through the Office of Management and Budget (OMB) to get information so that we can make assessments as to the extent that current research is addressing the priority work of the five research areas identified in the research needs report.
As for a completion date, NEHI will be in a better position to define this following our receipt and assessment of the information on the current research programs funded under the NNI. We see ourselves moving expeditiously to address the issues and produce a report that is credible and endorsed by all the U.S. Government's agencies represented in NEHI. In the meantime, research related to all five research areas is continuing to be supported in increasing amounts by NNI agencies, including the Environmental Protection Agency (EPA), the National Science Foundation (NSF), the National Institute for Occupational Safety and Health (NIOSH), the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Energy (DOE).
We understand the importance of this issue to the Committee and to the United States maintaining its dominance in the development of nanotechnology that is safe for both the U.S. consumer and the environment. We believe that the process we are following will enable achievement of these goals.
Q2. In your written testimony, you say that the NEHI working group ''will only serve in an advisory capacity'' with respect to setting priorities for research on environmental and safety impacts of nanotechnology. In the Q&A during the hearing, Dr. Bement said that the role of setting budget priorities is for the Office of Science and Technology Policy and the Office of Management and Budget. Does the NEHI have any role in the budget setting process of individual agencies or the White House Office's of Science and Technology Policy or Management and Budget? If so, how? If not, should it?
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A2. NEHI plays a valuable role in the budget-setting process of those agencies that fund nanotechnology Research and Development (R&D). Through the interagency process, reports like the research needs document represent the consensus of all NEHI member agencies, including those that do not have nanotechnology R&D budgets, and both the Office of Science and Technology Policy (OSTP) and OMB. The work of NEHI provides input to the NNI agencies that fund nanotechnology R&D and through the development of these documents, informs and provides guidance to the respective budget formulation processes for each agency. It is through this process that the NNI agencies that do not have nanotechnology R&D funding, yet that have a mission interest, have an impact on those agencies that have nanotechnology R&D funding. In addition, the NEHI process provides for the development of mutual decisions on the direction of EHS funding in the budget setting process involving the individual agencies and OMB.
Q3. In Dr. Maynard's testimony, he reported that the Federal Government is spending less on research on environmental and safety issues than the Federal Government claims it is spending. Why do his estimates differ so greatly from the figures reported by the Administration? What do you need to do to reconcile your figures with his? Are detailed accountings of the each agency's spending estimates available? If so, would you please provide them to the Committee?
A3. The funding amounts reported in the NNI Supplement to the President's 2006 and 2007 Budgets for spending on the environmental health and safety (EHS) research to understand the implications of engineered nanoscale materials were obtained from the Office of Management and Budget. Considerable care was exercised by OMB to obtain the best funding numbers from those agencies funding research on this topic. The intentionally restrictive definition developed by the involved agencies and used by OMB was chosen to aid program managers in making clear decisions about which projects and efforts to include in their funding estimates. The definition used by OMB in their request to the agencies was:
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Research and development on the environmental, health, and safety (EHS) implications of nanotechnology includes efforts whose primary purpose is to understand and address potential risks to health and to the environment posed by this technology. Potential risks encompass those resulting from human, animal, or environmental exposure to nanoproducts—here defined as engineered nanoscale materials, nanostructured materials, or nanotechnology-based devices, and their byproducts.
With such a restrictive definition, it is doubtful that the Federal Government estimates of funding for this research topic are overestimates. In fact, the research topics being proposed by other countries for inclusion under EHS research on nanotechnology include several types of research not included in the definition given above. A key example is research to develop instrumentation and metrology for characterizing the properties of engineered nanoscale materials. Most researchers in this field now recognize that knowledge of the purity of materials used in EHS studies is key to obtaining reproducible results among research studies.
Dr. Maynard's estimates for the Federal Government's spending on EHS R&D likely differ from the Federal Government's estimates because he did not have full access to funding data from all the agencies involved in this research, and he apparently does not agree with the definition used by the Federal Government.
A detailed breakdown—beyond the agency-by-agency data provided in the NNI Supplements to the President's Budgets—of the estimated funding for EHS R&D is not available at this time. As indicated in the ''Environmental, Health, and Safety Research Needs for Engineered Nanoscale materials'' document, development of a more detailed breakdown of each agency's spending estimates is part of the next steps to be taken by the Federal Government as we move forward with our assessment of the research needs in this R&D area.
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Q4. In his testimony at the hearing on September 21, Dr. Andrew Maynard from the Wilson Center recommended that the government should ask the Board on Environmental Studies and Toxicology of the National Academies of Science to help develop a long-term research agenda and conduct rolling reviews for nanotechnology environmental and safety research. Dr. Maynard also recommended that the government should contract with the Health Effects Institute to manage and/or perform some of the highest priority research. What is your view of Dr. Maynard's recommendations?
A4. The National Academies of Science (NAS) is already tasked to provide a rolling review of the NNI. It would be appropriate to ask the NAS to include the other NAS Boards in the triennial review of NNI. As for the involvement of a third party organization such as Health Effects Institute to conduct nanotechnology health and environment research, this can be an effective means to address specific needs when there is a commitment by both industry and government to provide sustained funding. Without this commitment, it can become unproductive. We are not aware of a nanotechnology industry group that can provide the sustained funding necessary to support this research.
Questions submitted by Representative Bart Gordon
Q1. The EMS research needs report released at the hearing includes several ''next steps'' (page 10 of the report) for the NEHI working group. What is the estimated timeframe or developing the specific EMS research priorities, evaluating in detail the current federal EMS research portfolio, and performing a gap analysis of current EHS research compared to prioritized needs?
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A1. The NEHI will begin work immediately to address the ''next steps'' identified in the ''Environmental, Health, and Safety Research Needs for Engineered nanoscale Materials'' EHS report. The representatives of the sixteen U.S. Government agencies are the most experienced and scientifically qualified in the U.S. Government to consider nanotechnology issues. They all recognize the importance of completing this effort as part of the United States' commitment to realizing the benefits of nanotechnology in a manner that is responsible and that protects health and the environment.
An important next step is development of a more detailed inventory of the research currently being conducted by the NNI funded agencies. This will involve working through the OMB to get information so that we can make assessments as to the extent that current research is addressing the priority work of the five research areas identified in the research needs report.
As for a completion date, we will be in a better position to define this following our receipt and assessment of the information on the current research programs funded under the NNI. We see ourselves moving expeditiously to address the issues and produce a report that is credible and endorsed by all the U.S. Government's agencies represented in NEHI. In the meantime, research related to all five research areas is continuing to be supported in increasing amounts by NNI agencies, including EPA, NSF, NIOSH, NIH, DOD, and DOE.
We understand the importance of this issue to the Committee and to the United States maintaining its dominance in the development of nanotechnology that is safe for both the U.S. consumer and the environment. We believe that the process we are following will enable achievement of these goals.
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Q2. In responses to questions at the hearing, the agency witnesses seemed to be saying the current planning/coordinating mechanism for EHS research based on the NEHI working group will be able to produce an EHS research plan or roadmap, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. What adjustments are needed to the way NEHI functions or to the way it is staffed to achieve this goal in a timely way?
A2. Adjustments are not needed at this time in order for the NEHI to perform a gap analysis and to address any areas that such an analysis might suggest are not being adequately investigated. NEHI members represent sixteen agencies, plus OMB and OSTP. NEHI is supported by the full-time staff of the National Nanotechnology Coordinating Office. The sixteen agencies include agencies that have nanotechnology R&D budgets, as well as those that do not, but that have a mission interest in the subject.
The NEHI process is significant in terms of the credibility of the products produced. It is not a top-down process. The NEHI process is a collaborative approach to very complex, scientific issues. The collaboration brings to bear the collective expertise of the many agencies involved and provides for their ongoing buy-in-this would not be achieved with a top-down approach. NEHI members also recognize the importance of public input in this process and will develop the means to achieve this objective. We also recognize that the process of obtaining public input adds to the time required.
NEHI does not produce funding targets for the NNI funded agencies. The NEHI report serves to inform and guide the funding agencies in their respective funding processes, which involve OMB.
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All the NEHI agencies endorse the continuation of the process followed in the development of the NEHI EHS Report. This collaborative process takes time, but the process is sound and in the best interest of the United States in maintaining its dominance in the development of nano-engineered products that are safe to both the U.S. consumer and the environment.
Q3. How frequently does the NEHI working group meet (include the schedule of meetings during the past 12 months), and do most members attend meetings (provide the list of current members)?
A3. The NEHI Working Group has met on an approximately monthly schedule starting in March 2004. As requested, the meeting schedule for the past 12 months is provided in Enclosure 1. This schedule omits many meetings, both face-to-face and teleconference meetings, by several drafting groups during the six months prior to the publication of the research needs document. Over 75 percent of the NEHI Working Group members normally participate in the meetings. A roster of current members of the NEHI Working Group is provided in Enclosure 2.
Q4. Does the NEHI working group attempt to develop a funding target for the overall EHS research effort under the NNI, as well as funding requirements to achieve specific research goals? What was the role of the NEHI working group in developing the funding estimate for EHS research shown in the FY 2007 NNI budget supplement report?
A4. The NEHI does not incorporate any funding considerations for EHS research under NNI in any of its report development. NEHI was not involved, as a body, in developing funding estimates for the fiscal year 2007 NNI budget supplement report. Individually, NEHI members, representing their respective agencies on the Nanoscale Science, Engineering and Technology (NSET) Subcommittee, were involved.
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NEHI's process provides for the development of collaborative reports for which there is buy-in during the development process by all the agencies involved. This process also involves OMB, a significant collaborator in the development of the required agency budgets.
Q5. Do you believe the NEHI working group's charter prevents or impedes it from developing budget requirements for achieving EHS research objectives?
A5. According to the NEHI charter, one purpose of the working group is to ''facilitate the identification, prioritization, and implementation of research and other activities required for the responsible research, development, utilization, and oversight of nanotechnology, including research on methods of life-cycle analysis.'' Agency budgets must be developed within the larger context of agency missions and priorities. By developing a consensus among NEHI members regarding priorities in the area of EHS research related to nanomaterials, NEHI enables the agencies that fund research related to engineered nanoscale materials to better assess and justify programs in this area within their own organization and to OMB.
Q6. By what means do industry and other interested non government entities have their views considered by the NEHI working group? Does NEHI hold any open meetings with non-government attendees?
A6. In the development of the NEHI EHS Report, other reports were used as information sources. Specifically, a report developed by the chemical and semiconductor industries was used. We also reviewed reports from the Royal Society/Royal Academy of Engineering in the United Kingdom and a report funded by the European commission.
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In past meetings of NEHI, we have had presentations from non-government organizations including the Chemical Abstract Service, March 2004; Intel, Cooperative Boards for Advancing Nanotechnology-EHS, on the group's suggested research targets, October, 2005; and National Research Council's Board on Environmental Studies and Toxicology, March, 2005. We will continue to take advantage of these opportunities as we continue our work.
All members of NEHI are committed to a more formal process that involves the industry and other interested non-government experts, especially in identifying priority areas. The development of this process will be a priority for NEHI as we address the next steps identified in the first NEHI document on environment, health, and safety of engineered nanoscale materials.
Q7. Has the NEHI working group attempted to coordinate EHS research funded under the NNI with related research being carried out abroad?
A7. In furtherance of the efforts of the NSET Subcommittee and NEHI to address the significant issues of nanotechnology standards development, NSET and NEHI members are working in a collaborative manner with representatives from this industry and academia, and with our non-U.S. counterparts. This activity includes participation by NSET and NEHI members on the American National Standards Institute Technical Advisory Group to the International Organization for Standards Technical Committee on Nanotechnologies, ASTM International E56 Committee, and the Institute of Electrical and Electronics Engineers Committees on Nanotechnology. Additionally, members are collaborating with the U.S. National Committee Technical Advisory Group for the newly formed International Electrotechnical Commissions' technical committee (TC) 113, on Nanotechnology Standardization for Electrical and Electronic Products and Systems.
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In addition, the nanotechnology funded agencies, through their normal activities with their foreign counterparts, will collaborate, where appropriate. This would not be an activity of the NEHI, but relevant information would be reported to NEHI.
Recently, the Global Issues in Nanotechnology Working Group (GIN) was chartered as a formal working group under the NSET. Chaired by the State Department, it has representation from the offices of the NNI participating agencies that handle international science and technology issues. The GIN provides review, input, and feedback on documents and other materials for international activities that relate to nanotechnology.
Just getting underway is an international activity within the Organization for Economic Cooperation and Development. A new working party on manufactured nanomaterials is meeting for the first time this month in London. The main objective will be to address issues related to environmental, health, and safety implications of manufactured (or engineered) nanomaterials, including sharing information on research efforts underway and identifying opportunities for cooperation. The NNI participation in this effort will be coordinated through both the NEHI and the GIN.
Q8. In his testimony at the hearing, Dr. Maynard suggested a mechanism for government to partner with industry to fund EHS research that would support the needs of government in formulating a regulatory framework for nanomaterials and the needs of industry on how to develop nanotechnology safely. The idea is to use the Health Effects Institute model, which studies the health effects of air pollution. What are your views on this suggestion: would this be a workable approach for instituting a government/industry partnership for support of EHS research related to nanotechnology?
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A8. The involvement of a third party organization such as Health Effects Institute to conduct nanotechnology health and environment research can be an effective means to address specific needs when there is a commitment by both industry and government to provide sustained funding. Without this commitment, it can become unproductive. We are not aware of a nanotechnology industry organization that can provide the sustained funding necessary to support this research.
29852r.eps
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ANSWERS TO POST-HEARING QUESTIONS
Responses by Arden L. Bement, Jr., Director, National Science Foundation
Questions submitted by Chairman Sherwood L. Boehlert
Q1. In his testimony at the hearing on September 21, Dr. Andrew Maynard from the Wilson Center recommended that the government should ask the Board on Environmental Studies and Toxicology of the National Academies of Science to help develop a long-term research agenda and conduct rolling reviews for nanotechnology environmental and safety research. Dr. Maynard also recommended that the government should contract with the Health Effects Institute to manage and/or perform some of the highest priority research. What is your view of Dr. Maynard's recommendations?
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A1. The National Research Council (NRC) completed its report on the National Nanotechnology Initiative (NNI) with a special section on Environmental, Health and Safety (EHS) in October 2006. The report was requested by Congress and was sponsored by NNI participating agencies. The report evaluated the status of EHS research and provides general guidance for future work. A subsequent NRC study will begin in 2007, and EHS issues will be addressed. The NRC will conduct rolling reviews for nanotechnology, including EHS. The NRC panel may be asked to address additional issues, and include the Board on Environmental Studies and Toxicity in the evaluation. However, another parallel study would be duplicative.
Regarding the issue of management and performance of highest priority research, the mission-oriented agencies are best equipped to address various aspects of the EHS issues. The problems are too complex and diverse to be addressed by a single group in a single institute. A coordinated approach among existing federal agencies is appropriate. A single institute may not have the expertise in all areas, and may not be able to respond effectively in a fast evolving field. In addition, we believe that basic research funding should be accomplished through a competitive, merit-based process.
Q2. Does the National Science Foundation (NSF) issue targeted solicitations for research focused on specific potential environmental or safety risks associated with nanotechnology? If not, please explain how NSF addresses the highest priorities in nanotechnology environmental and safety research? Are there are additional ways to target NSF's solicitations to specific risk-based questions, while still preserving the strengths of NSF's investigator-driven model of research?
A2. The annual NSF program solicitation ''Nanoscale Science and Engineering'' in the interval FY 2001–2005 included one theme related to nanoscale processes in the environment and another theme on societal implications. The NSF program solicitation ''Active Nanodevices and Nanosystems'' in FY 2006–2007 has a major theme on societal dimensions of nanotechnology. In the last two years (FYs 2006–2007) NSF has partnered with the Environmental Protection Agency (EPA), National Institute for Occupational Safety and Health (NIOSH) and the National Institute of Environmental Health Sciences (NIEHS) for a separate program solicitation on toxicity. All themes are aligned with the NSF mission of creating fundamental knowledge, establishing the infrastructure including human resources, and supporting nanotechnology education. NSF plans to continue to emphasize the EHS and Ethical, Legal, and Societal Implications (ELSI) areas. We will include environmental aspects in program descriptions, and support workshops to stimulate proposals in the field.
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NSF co-sponsored the first (2000) and second (2003) workshops on Societal Implications of Nanoscience and Nanotechnology in order to highlight the key research topics. NSF co-sponsored with EPA and the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee the grand challenge workshop on the environment; the report on those proceedings is expected to be published in November 2006. Also, NSF organized other topical workshops on the environment to identify the research trends and stimulate interest in the community.
Q3. How has NSF decided how much money to allocate to nanotechnology environmental and safety research? Why is the funding level proposed in NSF's fiscal year 2007 budget request so low compared to what is recommended by the Wilson Center and by Lux Research?
A3. NSF identifies key knowledge gaps and the level of funding needed to address the issues through the process described in the following paragraph. Because of NSF's critical impact on building a fundamental body of knowledge, specialized facilities and qualified people, NSF funds a large fraction of the overall NNI investment in Societal Dimensions: $59 million (72 percent) of the $82.1 million total in the FY 2007 Request, and $51.5 million (72 percent) of $71.7 million in the FY 2006 estimation (see The NNI—Supplement FY 2007 Budget, page 36–37). Of the total NSF contribution to NNI ($373 million), about 16 percent is for societal dimensions of which seven percent is specifically for EHS. These percentages are in the range of those recommended on average for all of NNI by the Woodrow Wilson Center (WWC) and Lux Research (about four percent for EHS recommended by WWC and about nine percent recommended by Lux Research on average for all agencies).
The NSF funding level is established following an annual evaluation process where input is sought from the research community, industry, and other organizations. All NSF proposals under NNI are evaluated by merit review. Also, NSF has an annual process of establishing overall priorities for nanoscale science and engineering research, including:
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(a) NSET Subcommittee: Results from periodic workshops and meetings with the communities are synthesized by program directors and discussed in the NSET Subcommittee and its working groups;
(b) National context: NSF contributes to and coordinates its NNI research and education activities through the Nanoscale Science, Engineering and Technology Subcommittee (NSET) of the National Science and Technology Council (NSTC), as a cross-cutting priority reported to the Office of Management and Budget (OMB), and a national priority of the Administration. NSF participates in all NNI workshops, research directions and planning meetings and is coordinating its program with the work done by other agencies in the general context of R&D, infrastructure and education needs;
(c) International context: NSF organized the first ''International Dialogue on Responsible Nanotechnology'' conference which included 25 countries and the European Union (EU) and was held in the U.S. in June 2004, and contributed to the second in July 2006 in Japan. Other international interactions have been developed with the Organization for Economic Cooperation and Development (OECD), international standards and other international organizations. NSF organized bilateral meetings with the European Commission, Japan, Korea, Switzerland, India, China, Ireland, and others in order to identify research directions and develop collaborations. NSF has recently funded an international project on identifying EHS research needs, and has interactions with the EU and Japan on future joint research funding activities in societal dimensions;
(d) Industry perspective: A joint NNI-industry working group on EHS with the electronic and chemical industries has resulted in a report on EHS Research Needs (2005) and periodically provides input to NSF staff;
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(e) Public and Non-Governmental Organizations (NGOs): NSF receives feedback through surveys and periodical interactions. For example, NSF has supported surveys that are used as a reference in setting up the new Network for Nanotechnology in Society. All Nanoscale Science and Engineering Centers (NSEC) and nanotechnology networks supported by NSF are encouraged to have public outreach activities, and two networks have a well-defined task in this area, the Network for Nanotechnology in Society and the Network for Informal Science Education;
(f) Annual Grantees Meetings and other evaluation activities: NSF's Committees Of Visitors (COVs), NSF's Directorate Advisory Committees, OMB's Program Assessment Rating Tool (PART), Presidential Council of Advisors for Science and Technology (PCAST) review);
(g) Interagency Coordination via NSTC/NSET and its three working groups: Nanomaterials Environmental and Health Issues (NEHI), Nanotechnology Innovation and Liaison to Industry (NILI), Global Issues in Nanotechnology (GNI), and Nanotechnology Public Engagement Group (NPEG).
Q4. In your testimony on September 21, you laid out some specific priorities for nanotechnology environmental and safety research. To what extent do these priorities overlap with the research that other federal agencies are sponsoring? To what extent do these priorities fill research gaps identified in the Wilson Center report? Of the research priorities that the Wilson Center identified, are there some priorities that NSF does not plan to investigate?
A4. There is very little, if any, overlap. The topics covered by NSF align with the agency's mission and cover some of the top recommendations made by both WWC and Lux Research for fundamental understanding, infrastructure, and education in the field of nanotechnology. The mission-oriented goals for testing the toxicity of specific nanomaterials and exposure to the digestive system are best covered by the respective mission oriented agencies.
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Q5. Please explain the degree to which, and how, NSF's agenda for nanotechnology environmental and safety research is shaped by interagency coordination, and how it is shaped by the need to inform potential regulation.
A5. NSF coordinates closely with other agencies in planning to eliminate duplication of effort and ensure effective knowledge transfer. NSF's agenda in this area is defined by the fundamental knowledge gaps, infrastructure and education needs.
NSF develops its strategic and annual planning, and its collaboration with other participating agencies in NSET and NSET's Nanomaterials Environmental and Health Issues (NEHI) Working Group. NSF conducts fundamental research in EHS according to its mission, which complements the more practical approach of EPA, toxicity studies by the National Institutes of Health (NIH), and regulatory activities by the Food and Drug Administration (FDA) and NIOSH. This research provides a broad-based foundation of knowledge, trained people and suitable laboratory infrastructure for the mission-specific applied R&D done by the regulatory agencies. NSF-sponsored research and education results have long-term, broad impact and may be used by multiple agencies. All NSF awards are listed on the web site and searchable by programs, authors, and keywords. In addition, NSF has communicated its results at periodic interagency meetings and workshops, including grantees workshops.
Questions submitted by Representative Bart Gordon
Q1. NSF funds well over half of all EHS research under the NNI. How specific are NSF's announcements to the research community regarding funding opportunities in this area? That is, does NSF direct the attention of potential grant awardees to research questions of high relevance to the regulatory agencies responsible for dealing with the human health and environmental risks of nanomaterials, and what percentage of the EHS funding available from NSF would fall into this category of directed basic research?
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A1. NSF has allocated a high percentage of its investment in nanotechnology in the EHS area in order to define the key science and engineering issues, prepare the scientific foundation for environmental implications, develop the research infrastructure and train suitable workers in the field. NSF conducts fundamental research in EHS according to its mission, which complements the more practical approach of EPA, toxicity studies by NIH, and regulatory activities by FDA and NIOSH. NSF has encouraged research in the fundamental aspects of EHS partially by its program solicitations and several core program descriptions, as well as workshops and conferences on these topics.
Q2. In his testimony at the hearing, Dr. Maynard suggested a mechanism for government to partner with industry to fund EHS research that would support the needs of government in formulating a regulatory framework for nanomaterials and the needs of industry on how to develop nanotechnology safely. The idea is to use the Health Effects Institute model, which studies the health effects of air pollution. What are your views on this suggestion? Would this be a workable approach for instituting a government/industry partnership for support of EHS research related to nanotechnology?
A2. We believe that fundamental research on nanotechnology EHS issues will be advanced most effectively by supporting researchers at academic institutions using merit review. The role of government is in creating the knowledge foundation for industry to apply knowledge, general principles and reference data to various applications. It is not clear that placing all resources in one place for a complex problem with multiple stakeholders (government, various industries with proprietary claims, public, NGOs) would lead to superior results.
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Q3. In responses to questions at the hearing, the agency witnesses seemed to be saying the current planning/coordinating mechanism for EHS research based on the NEHI working group will be able to produce an EHS research plan or roadmap, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. What adjustments are needed to the way NEHI functions or to the way it is staffed to achieve this goal in a timely way?
A3. NEHI is a working group that provides coordination in the field of EHS and reports to NSET. NEHI plays an advisory role to agencies. The Office of Science and Technology Policy (OSTP) and OMB coordinate the research and development plans, set priorities with input from agencies, and approve budgets for NNI each year, including for EHS efforts. Accordingly, only agencies with financial responsibility and under guidance from OMB and OSTP can set priorities and allocate funding. No changes are needed in the NEHI function and staffing.
Questions submitted by Representative Brad Sherman
This hearing focuses on the safety impacts of nanotechnology. I have concerns about the implications of nanotechnology that have not yet been adequately addressed and are often incorrectly dismissed as ''science fiction.'' It is said that computer engineering can be referred to as ''dry nanotechnology,'' that generic engineering can be referred to as ''wet nanotechnology,'' and that the implantation of computer chips and similar devices into a human or other biological organism is ''damp nanotechnology.'' Thus, the term nanotechnology encompasses the most interesting cutting-edge scientific research. It seems the science that will affect our lives in the biggest way is mighty small, in fact, nano-small. All three types of nanotechnology could well lead to what I call ''engineered intelligence,'' i.e., the creation of self-aware entities with intellectual capacities for exceeding the brightest human. Computer engineering (dry nanotechnology) is likely to create artificial intelligence exceeding humans within 25–30 years, according to the consensus of experts who testified before our committee on April 9, 2003. The time will come when genetic engineers will be able to create a 1,000 pound mammal with two fifty pound brains capable of a perfect score on the LSAT. And perhaps the first entities with superhuman intelligence will be humans with substantial computer chip implants capable of thinking in ways no ordinary human has. In any case, I refer to all three of these nanotechnologies (dry, wet and damp) when I use the term engineered intelligence.
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Dr. Bement, in your written testimony you mention the three main categories of what the National Science Foundation (NSF) characterizes as the ''societal dimensions'' of nanotechnology and you also go on to say that each of these categories is indispensable. My concern falls within the category of ''ethical, legal and other social issues.'' The ethical and societal repercussions of engineered intelligence should be studied.
Q1. Please describe in detail the projects that are funded by the National Science Foundation, which address the ethical and societal concerns accompanying the development of nanotechnology. Which of these focus on engineered intelligence in general or artificial intelligence in particular? If there are no such projects, what is the NSF's plan to promote studies addressing these concerns?
A1. The National Science Foundation is investing $4.8 million in FY 2006 and is seeking $5.4 million in the FY 2007 Request to Congress for ethical, legal, and social issues research and education. The NSF is funding several projects addressing ethical and social concerns of nanotechnology including: two major centers devoted to the examination of nanotechnology in society at the University of California Santa Barbara (UCSB) and Arizona State University (ASU); two nanotechnology in society research groups, one at Harvard/UCLA and the other at the University of South Carolina; two grants for Nanotechnology Interdisciplinary Research Teams (NIRTs) at the University of Minnesota, and Northeastern; several Nanotechnology Exploratory Research (NERs) grants; two Ethics Education in Science and Engineering (EESE) grants that involve ethical issues associated with nanotechnology; and several standard research grants funded through NSF programs. In addition, the National Nanotechnology Infrastructure Network (NNIN) includes activities related to societal and ethical issues, and a number of Nanoscale Science and Engineering Centers (NSECs) include research components on societal and ethical issues. Most of these projects address a range of mid- and long-range ethical and societal issues including personal privacy, security, identity, human enhancement, regulatory capacity, public perceptions and acceptance, and media coverage.
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Although none of the above projects specifically addresses the ethical and societal issues of engineered intelligence or artificial intelligence, three projects directly engage ethical issues associated with nanotechnology and human enhancement. The Center for Nanotechnology in Society at ASU has a research focus on human identity, enhancement and biology. The NSEC for Molecular Function at the Nano/Bio Interface at the University of Pennsylvania has an ethics component. A recently awarded standard research grant to scholars at Dartmouth and Western Michigan University will examine ethical issues associated with human enhancement and nanotechnology, particularly those that may be made possible with nanomaterials and nanoelectronics, e.g., nanotechnologically-augmented vision.
Q2. It is widely recognized that information about the risks of nanotechnology, to be useful, needs to be communicated to the potential users of that information in an effective way. Information that is not the product of an ongoing dialogue with various stakeholders, such as public health officials, theologians, philosophers, representatives of non-profit organizations, the private sector, and the general public, is not likely to be seen as credible by such stakeholders. Dr. Bement, please describe for me the NSF's plan for ensuring an ongoing dialogue with the public about nanotechnology issues so that the results of ethical and societal studies are valuable and usable for stakeholders. Please particularly focus on the ethical and societal research regarding the impacts of nanotechnology's potential creation of engineered intelligence in each of the three forms I have outlined above.
A2. NSF has activities in formal and informal education for nanotechnology, as well as public surveys and public participation. For nanotechnology education and outreach alone, NSF has allocated $24.5 million in FY 2006 and $28.0 million in the FY 2007 Request to Congress.
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We have several projects that specifically address the need to ensure an ongoing dialogue with the public on nanotechnology.
Nanotechnology: The Convergence of Science and Society (ESI–0452371, Oregon Public Broadcasting, Needham) is producing three one-hour television programs for national broadcast on the social, ethical, legal, and environmental implications of nanotechnology based on the Fred Friendly Seminar format, accompanied by community-based outreach efforts and a web site.
The Nanoscale Informal Science Education Network (ESI–0532537, Museum of Science, Bell), which is creating exhibits and media to educate the public about nanoscience and technology, includes development and implementation of public forums in science museums designed to engage adults in discussing potential societal impact.
Other projects, such as Earth & Sky Nanoscale Science and Engineering Radio Shows (ESI–0426417, EarthTalk Inc., Britton) that will increase general public awareness of nanotechnology and its role in our lives.
There are numerous other activities associated with the projects outlined in the answer above that are designed to foster an ongoing and informed dialogue with various stakeholders including the public. For example, Science Cafes, at which nano-scientists talk about their research and afford members of the public an opportunity to raise questions and concerns, are being held on a regular basis at the University of Wisconsin and ASU. The University of South Carolina has organized several Citizens' Schools of Nanotechnology where members of the public read and discuss nanotechnology and related societal issues over a several-week period. The Harvard/UCLA research project is developing a pilot NanoEthicsBank providing an online database of articles, journals, reports, and meeting minutes related to nanotechnology and ethics; the NanoEthicsBank is accessible to the public and other stakeholders. Several projects, including those at ASU, UCSB, and North Carolina State, have public deliberation activities related to nanotechnology and society. Finally public opinion surveys, as well as scientist surveys, associated with various aspects of nanotechnology and society are being conducted as part of a number of these projects. In all these instances, the local media are utilized to inform the public about the activities.
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In addition to the activities focusing on public knowledge, understanding and concerns, several workshops on nanotechnology and society issues have been held in conjunction with NSF funded projects. At these, representatives from academia, non-profits, government and industry have participated. For example, Michigan State held a workshop on what nanotechnology can learn from the experiences of biotechnology. A workshop on ethical issues and nanotechnology is being planned and will be held at ASU.
Q3. Roughly two percent of the National Science Foundation's FY 2007 request for the National Nanotechnology Initiative goes to ''ethical, legal, and social issues,'' while about eight percent is directed toward environmental, health and safety research. Dr. Bement, you state in your submitted testimony that ''ethical, legal, and social issues'' are an important dimension of the study of nanotechnology's societal issues. Then, why is so little of the funding for the National Nanotechnology Initiative (NNI) directed towards the ''ethical, legal, and social issues'' category?
A3. The support for ''ethical, legal, and social issues'' was determined by the need for funding the relevant and meritorious social sciences projects, the level of current developments in the field and formation of a multi-disciplinary community, and the funding needs of competing areas such as Environmental, Health and Safety (EHS). The current investment is beginning to create a community with critical mass for advancing research and understanding of the ethical, legal and social issues associated with nanotechnology.
Now, leaving the issue of engineered intelligence, I have some general questions about the NNI which are frankly less important to me than the previous questions, but I hope you will answer them at your convenience.
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Q4. Is your agency involved in a systematic assessment of emerging products of nanoscale science and engineering so that you can identify possible new sources of risk at the earliest possible stage?
A4. NSF co-organized a grand challenge workshop on the environment, supports four centers for partial support of this topic, and initiated the industry-government working groups on EHS in 2003. NSF does not directly evaluate products, as that is a role that is more pertinent to other agencies and industry.
Q5. Is your agency involving researchers in the process of identifying and prioritizing research problems, to ensure that research agendas are responsive to stakeholder concerns? What societal research are you supporting to help identify the various ways that nanotechnology risk is being framed by researchers? If you are not engaged in such work, why are you confident that the research you are funding will be valuable for stakeholders?
A5. NSF provides opportunities for stakeholder input through its process of establishing priorities, including workshops with various communities, joint working groups, direct interactions, grantees meetings, and interagency exchanges. For example, NSF supports projects on safety in manufacturing, occupational health issues, implications for food and agriculture, as well as for long-term societal implications.
NSF is supporting research on different approaches to risk assessment and risk perception for nanotechnology. For example, the University of Wisconsin is studying the effect of nanotechnology on food production and risk perception. NSF is funding research and education activities to assess risk for the current and future generations of nanoproducts. All projects are subject to peer review where stakeholders are invited to participate.
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Q6. According to a Congressional Research Services document, the Administration's FY 2007 request for the National Nanotechnology Initiative is a four percent decline in real dollars than what was enacted in FY 2006. Why would we decrease the funding, given the importance of the research?
A6. The Request for NNI investment has increased each year including in FY 2007 ($1,278 million) as compared to the FY 2006 Request ($1,054 million).
ANSWERS TO POST-HEARING QUESTIONS
Responses by William H. Farland, Deputy Assistant Administrator for Science, Office of Research and Development, U.S. Environmental Protection Agency
Questions submitted by Chairman Sherwood L. Boehlert
Q1. In his testimony at the hearing on September 21, Dr. Andrew Maynard from the Wilson Center recommended that the government should ask the Board on Environmental Studies and Toxicology of the National Academies of Science to help develop a long-term research agenda and conduct rolling reviews for nanotechnology environmental and safety research. Dr. Maynard also recommended that the government should contract with the Health Effects Institute to manage and/or perform some of the highest priority research. What is your view of Dr. Maynard's recommendations?
A1. The National Academies of Science (NAS) provides periodic reviews of the government activities under the National Nanotechnology Initiative (NNI) as required by the 21st Century Nanotechnology Research and Development Act of 2003. The NNI is managed within the framework of the National Science and Technology Council (NSTC), the Cabinet-level council by which the President coordinates science, space, and technology policies across the Federal Government. The Nanoscale Science Engineering and Technology (NSET) Subcommittee of the NSTC coordinates planning, budgeting, program implementation and review to ensure a balanced and comprehensive initiative. The NSET Subcommittee is composed of representatives from agencies participating in the NNI.
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The NSET Subcommittee members value its relationship with NAS and hope to use it in the future to receive input and feedback from the Board on Environmental Studies and Toxicology (BEST) and other NAS Boards on research directions and priorities related to environmental, health and safety. However, the agencies that participate in NSET and its Nanotechnology Environmental and Health Implications Working Group (NEHI) have already made significant progress toward a long-term research agenda with the publication in September of the report ''Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials,'' and are committed to taking steps immediately to establish priorities for their research needs Given this progress, it seems most effective to utilize BEST and other NAS bodies to review, rather than to establish, an additional long-term research agenda. EPA believes that the current NAS role provides timely and appropriate input to the government's research agenda.
EPA supports collaboration with the private sector and other stakeholders. While EPA has a positive relationship with the Health Effects Institute on air pollution research, we believe it is too early to conclude that the same model is appropriate for nanotechnology environmental and safety research. On October 18, EPA announced its intent to develop a stewardship program that would provide a valuable collaboration with industry and other stakeholders, and which we expect to result in significant new information being made available on nanomaterials. EPA is inviting the public, industry, environmental groups, other federal agencies and other stakeholders to participate in the design, development and implementation of this program. A successful stewardship program will complement the Agency's new and existing chemical programs under the Toxic Substances Control Act and can help provide a scientific foundation for regulatory decisions by encouraging the development of key scientific information and appropriate risk management practices.
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Q2. How has the Environmental Protection Agency (EPA) decided how much money to allocate to nanotechnology environmental and safety research? What impact will the report from the Nanotechnology Environmental and Health Implications Working Group have on EPA's nanotechnology research programs? What impact will it have on EPA's fiscal year 2008 budget request?
A2. Determinations of research budget priorities are made in the context of the Agency's overall priorities and budget needs in concert with the Agency program offices. EPA also has allocated resources to new, emerging issues, such as nanotechnology, through its Science to Achieve Results (STAR) exploratory grants. Initial results from this STAR nanotechnology research and research by others helped clarify research gaps and opportunities that were considered as EPA increased its nanotechnology budget request from FY06 to FY07. The EPA's FY08 budget process has been guided in part by the development of the Nanotechnology White Paper, which was released as a draft report in December 2005 for public comment. Over the past year, the process of developing the NEHI research needs document has provided additional insight into EPA's research needs. EPA has developed a nanotechnology research strategy framework which, along with the White paper should advance the NEHI efforts to develop an overall federal prioritized research strategy in this area.
Q3. In your testimony on September 21, you laid out some specific priorities for nanotechnology environmental and safety research. To what extent do these priorities overlap with the research that other federal agencies are sponsoring? To what extent do these priorities fill research gaps identified in the Wilson Center report? Of the research priorities that the Wilson Center identified, are there some priorities that EPA does not plan to investigate?
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A3. Our testimony on September 21 stated that EPA will conduct research to understand whether nanoparticles, in particular those with the greatest potential to be released into the environment and/or trigger a hazard concern, pose significant risks to human health or ecosystems. We stated that we are uniquely positioned to lead in the ecosystem and exposure areas. A research framework included in the White Paper identifies specific near-term priority research areas as fate, transport, transformation, exposure and monitoring, and detection technologies. The Agency has taken steps to ensure that the priority research areas will not overlap either with current research sponsored by other agencies or with their research priorities. EPA communicates regularly with other federal agencies concerning priorities through the NEHI and NSET and collaborates with other agencies on research solicitations to ensure that environmental and health issues are undertaken in a coordinated manner. For example, EPA has issued joint solicitations over the past two years with National Science Foundation, National Institute of Occupational Safety and Health and the National Institute of Environmental Health Sciences.
EPA's priorities are also consistent with those suggested in the Woodrow Wilson Center research document, which suggests the Agency give priority to the areas of exposure and monitoring/detection technologies with subsequent focus on ecotoxicity and life cycle approaches (found on pp. 34–36 of the report, http://www.nanotechproject.org/67/7-19-06-nanotechnology-a-research-strategy-for-addressing-risk). All of these areas are contained within the priorities identified in the recent testimony and the draft White Paper. While the Wilson Center report does not mention fate, transport and transformation explicitly, these areas are critical to understanding both exposure and toxicity—whether ecological or human—as well as life cycle considerations.
Q4. EPA released a draft white paper on its research needs for the environmental and safety impacts of nanotechnology for public comment last year. Your written testimony said that it complements the report released today. In what way are they complementary? When will the white paper be finalized? Will you be revising it based on today's report? Will the final version identify short-, medium- and long-term priorities?
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A4. The Nanotechnology White Paper was recently approved by the Agency's Science Policy Council, so EPA anticipates that the final version will be released to the public soon.
The draft White Paper provides an extensive review of research needs for both environmental applications and implications of nanotechnology. To help EPA focus on priorities for the near-term, the draft concludes with recommendations on the next steps for addressing science policy issues and research needs. In addition, it includes in Appendix C, a description of EPA's framework for nanotechnology research, which outlines how EPA will strategically focus its own research program (as outlined in the September testimony) to provide key information on potential environmental impacts from human or ecological exposure to nanomaterials in a manner that complements federal, academic, and private-sector research activities. Collaboration with other researchers is a major focus of the draft paper.
EPA was represented on the committee that developed the NEHI report, and played a key role in identifying research needs. As such, there is no need to modify the white paper since the two reports complement one other. The NEHI report was designed to give an overview of environmental, health and safety research needs for all federal agencies. The research needs identified in EPA's draft White Paper were included in the NEHI report. As the NEHI prioritizes needs, those areas that fall within the mission and expertise of the EPA will be addressed in the context of the Agency's overall research priorities and budget.
Questions submitted by Representative Bart Gordon
Q1. In his testimony at the hearing, Dr. Maynard suggested a mechanism for government to partner with industry to fund EHS research that would support the needs of government in formulating a regulatory framework for nanomaterials and the needs of industry on how to develop nanotechnology safely. The idea is to use the Health Effects Institute model, which studies the health effects of air pollution. What are your views on this suggestion: would this be a workable approach for instituting a government/industry partnership for support of EHS research related to nanotechnology?
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A1. EPA supports collaboration with the private sector and other stakeholders, and EPA has a positive relationship with the Heath Effects Institute on air pollution research. However, we believe it is too early to conclude that the same model is appropriate for nanotechnology environmental and safety research. On October 18, EPA announced its intent to develop a stewardship program that would provide a valuable collaboration that could result in significant new information that will help the Agency better understand the potential risks and benefits of nanotechnology. EPA is inviting the public, industry, environmental groups, other federal agencies and other stakeholders to participate in the design, development and implementation of this program. A successful stewardship program will complement the Agency's new and existing chemical programs under the Toxic Substances Control Act and can help provide a scientific foundation for regulatory decisions by encouraging the development of key scientific information and appropriate risk management practices.
Q2. In responses to questions at the hearing, the agency witnesses seemed to be saying the current planning/coordinating mechanism for EHS research based on the NEHI working group will be able to produce an EHS research plan or roadmap, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. What adjustments are needed to the way NEHI functions or to the way it is staffed to achieve this goal in a timely way?
A2. The Agency does not believe any alterations nor changes in the NEHI staffing or functionality are required to prioritize the research needs that are identified in the NEHI report. As indicated above, EPA has already developed its own prioritized research strategy, and will work with other agencies through the NEHI to develop a coordinated cross-agency set of research priorities in a timely manner.
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ANSWERS TO POST-HEARING QUESTIONS
Responses by Altaf H. (Tof) Carim, Program Manager, Nanoscale Science and Electron Scattering Center, U.S. Department of Energy
Questions submitted by Chairman Sherwood L. Boehlert
Q1. In his testimony at the hearing on September 21, Dr. Andrew Maynard from the Wilson Center recommended that the government should ask the Board on Environmental Studies and Toxicology of the National Academies of Science to help develop a long-term research agenda and conduct rolling reviews for nanotechnology environmental and safety research. Dr. Maynard also recommended that the government should contract with the Health Effects Institute to manage and/or perform some of the highest priority research. What is your view of Dr. Maynard's recommendations?
A1. Periodic reviews of the National Nanotechnology Initiative, specifically including environmental and safety aspects, are already required from both the National Academies and the President's Council of Advisors on Science and Technology (serving as the National Nanotechnology Advisory Panel) under P.L. 108–153. Initial reports from both groups have been issued (the Academies' review report, A Matter of Size: Triennial Review of the National Nanotechnology Initiative, was released in pre-publication form shortly after the hearing, on September 25th, 2006, and the PCAST report, The National Nanotechnology Initiative at Five Years: Assessment and Recommendations of the National Nanotechnology Advisory Panel, was issued in May 2006). Both reports discussed environmental, health, and safety aspects of the initiative and it is anticipated that this topic area will appropriately receive attention in subsequent reviews by these groups.
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Development of a long-term agenda for environmental and safety research is already underway via the interagency Nanoscale Science, Engineering, and Technology (NSET) subcommittee of the National Science and Technology Council and its subsidiary Nanotechnology Environmental and Health Implications (NEHI) working group. These activities are in the context of the missions, resources, and expertise of the participating agencies, and represent comprehensive coordination of federal efforts. The document prepared by NEHI and released on the date of the hearing, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, represents an initial step in the ongoing process of defining and evaluating these activities. Given the existing mandate for the National Academies to review these aspects of the National Nanotechnology Initiative and the time required from commissioning to final publication of a National Academies report, an additional review requirement by the National Academies in this area would not appear to be warranted or fruitful.
The Department of Energy is not involved with the existing work of the Health Effects Institute (HEI) and defers to other agencies with more expertise in this subject area. HEI appears to be focused on particular classes of problems, with roughly half of its core funding coming from ''the worldwide motor vehicle industry'' (as per its homepage, at http://www.healtheffects.org/about.htm). Government partnerships with, or support of, private parties can be appropriate and effective, though a preferable approach might be to define the needs and then consider competitive proposals to achieve the desired ends, rather than pre-selecting a specific party to manage and/or perform such work. This is best pursued in the context of agency missions, resources, expertise, and past experience.
Q2. In your testimony on September 21, you stated that the Department of Energy (DOE) supports research on potential environmental and safety risks associated with nanotechnology by providing uniquely capable synthesis and characterization tools, but you suggested that DOE does not sponsor or conduct targeted nanotechnology environmental and safety research. Given DOE's significant contribution to the National Nanotechnology Initiative (NNI), shouldn't DOE's contribute more directly to NNI's targeted environmental and safety research priorities?
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A2. As is the case for all the agencies involved in the NNI, DOE contributes to NNI goals and priorities in the ways which align most closely with the Department's mission, resources, and expertise. The distinct nature of each agency's nanotechnology programs reflects the ongoing interagency coordination and the corresponding efforts to avoid duplication and most effectively pursue such work. DOE solicitations have not focused specifically on nanomaterials environmental and safety research, though a limited amount of work with the primary purpose of understanding transport and ultimate disposition of nanoscale particles in the environment has been supported via competitive merit review as part of our geosciences research program. Other activities with important relevance to environmental and safety concerns include the operation of user facilities that provide capabilities for obtaining comparable, reproducible data; work on measurement and characterization techniques, including novel instrumentation; and development of standards and nomenclature. These activities include some which are critical and involve DOE and/or contractor staff but little or no direct funding, such as internal working group discussions of best practices among DOE-supported laboratories and participation in groups such as the American National Standards Institute and the International Organization for Standardization. Nevertheless, the Department intends to reassess its direct support of environmental and safety research as it relates to nanotechnology applications in DOE mission areas.
Q3. Please explain the degree to which, and how, DOE's investments in advanced nanotechnology facilities are shaped by nanotechnology environmental and safety research priorities, and how those investments are shaped by the need to inform potential regulation related to possible environmental and safety risks.
A3. The DOE Nanoscale Science Research Center user facilities investments have been shaped by a variety of factors including initial interagency discussions at the start of the National Nanotechnology Initiative, a series of planning workshops that attracted nearly 2,000 participants, definition of nanoscience research needs to address energy issues, and efforts to optimize the utility and accessibility of other major BES facilities for nanoscience. While the instrument suites and infrastructure investments over the past five years have not directly reflected recently-developed environmental and safety research priorities or regulatory needs, DOE representatives have made members of those communities aware of the resources that will be made available to them through the NSRCs via presentations to and meetings with program managers and grantees from EPA, USDA, NIH, NSF, and the NSET interagency group as a whole.
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The NSRCs are part of the scientific infrastructure of the Nation. They support the specific research missions of other agencies by providing access to unique capabilities and collections of instruments and expertise that are unavailable elsewhere or impractical for many individual organizations to obtain and support. The NSRCs also provide opportunities for collaboration. The methods and practices developed and used at the NSRCs allow the collection of comparable, I reproducible data across material types and across multiple research groups through the use of standardized platforms and procedures; such consistency in measurement and characterization is critical to understanding research issues.
Q4. How are priorities for nanotechnology environmental and safety research considered in DOE's budget and planning processes for nanotechnology research and development?
A4. The NSET–NEHI report and other external documents on nanotechnology environmental and safety research needs provide guidance; agencies then make their plans for activities in this area within the framework of the NSET report(s) and based on the input and directions identified by the interagency process, third parties, the community through workshops and discussions, and a variety of other means. In the case of DOE, the budget and planning processes for nanoscience and related activities center on the mission of the Office of Science, involving fundamental research in support of long-term energy security and discovery science, and forefront scientific user facilities for the Nation. The planning for nanoscience centers rests on the principles of broad access and of facilitating leading-edge research in all areas by providing a comprehensive suite of tools and expertise.
Questions submitted by Representative Bart Gordon
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Q1. In his testimony at the hearing, Dr. Maynard suggested a mechanism for government to partner with industry to fund EHS research that would support the needs of government in formulating a regulatory framework for nanomaterials and the needs of industry on how to develop nanotechnology safely. The idea is to use the Health Effects Institute model, which studies the health effects of air pollution. What are your views on this suggestion: would this be a workable approach for instituting a government/industry partnership for support of EHS research related to nanotechnology?
A1. (As answered as part of the response to Question #1 from Chairman Boehlert and repeated here.) The Department of Energy is not involved with the existing work of the Health Effects Institute (HEI) and defers to other agencies with more expertise in this subject area. HEI appears to be focused on particular classes of problems, with roughly half of its core funding coming from ''the worldwide motor vehicle industry'' (as per its homepage, at http://www.healtheffects.org/about.htm). Government partnerships with, or support of, private parties can be appropriate and effective, though a preferable approach might be to define the needs and then consider competitive proposals to achieve the desired ends, rather than pre-selecting a specific party to manage and/or perform such work. This is best pursued in the context of agency missions, resources, expertise, and past experience.
Q2. In responses to questions at the hearing, the agency witnesses seemed to be saying the current planning/coordinating mechanism for EHS research based on the NEHI working group will be able to produce an EHS research plan or roadmap, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. What adjustments are needed to the way NEHI functions or to the way it is staffed to achieve this goal in a timely way?
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A2. The very aspect of the NEHI working group that causes the process to be at times lengthy is also its strength: it synthesizes and reconciles input from the many agencies involved, and thus provides a coordinated and consensus output that is reflective of the overall U.S. federal position. We believe that the current NSET and NEHI structure is the best approach to engaging the needed expertise from the member agencies to do credible, effective, and implementable planning.
ANSWERS TO POST-HEARING QUESTIONS
Responses by Andrew D. Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars
Questions submitted by Chairman Sherwood L. Boehlert
Q1. In your testimony you indicated that the interagency working group is not able to carry out the important tasks identified in the Nanotechnology R&D Act, including assessing research gaps, setting priorities, and reviewing and directing agency budgets? How would you make NEHI more effective?
A1. First, I would suggest that the NEHI working group's position under the National Science and Technology Council Committee on Technology places it at an immediate disadvantage in ensuring that targeted research informs regulation and other forms of oversight. I will expand on my reasoning behind this statement below. If NEHI does continue to be the interagency group primarily responsible for ensuring effective nanotechnology risk-research across the Federal Government, then I would propose that three changes are essential if the group is to be effective in implementing relevant parts of the 21st Century Nanotechnology Research and Development Act:
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1. The charter of the NEHI working group must be modified to increase the group's charge and authority to establish and implement a strategic nano-risk research framework, which underpins nanotechnology oversight.
2. The NEHI working group must have the authority to ensure that appropriate agencies have the resources they need to conduct relevant, effective and coordinated risk research.
3. A full-time director, with appropriate staffing, must oversee the activities of the NEHI working group, with responsibility for developing and implementing a cross-agency strategic risk-research plan. The Director must be seen as an ''honest broker'' with no immediate ties to any government agency. The Director must also have direct access to key decision makers in both the White House and the Office of Management and Budget (OMB).
These changes will provide the tools NEHI needs to develop and implement an effective top-down strategic research framework across federal agencies, a framework that enables each agency to operate to maximum effect within its mission and competencies. However, by themselves, these changes will not guarantee success. Implementation of the recommended changes will require the support and commitment of all participating agencies, the Office of Science and Technology Policy (OSTP) and OMB. NEHI will also need new funding to cover critical research and support a full-time director. I have previously estimated that a minimum of $100 million over the next two years needs to be spent on targeted risk-related research, with additional funding for basic and applications-focused research with some relevance to understanding risk. I would suggest that mechanisms are needed whereby additional research funds can be allocated to agencies via the NEHI group to supplement current resource-starved programs—possibly through new funds being appropriated by a relatively neutral agency, and allocated out through interagency agreements. Effective resource allocation will depend on developing a strategic research agenda within NEHI, identifying the roles of research agencies within this agenda, and enabling cross-agency collaborations.
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I also recommended in my testimony to the House Committee on Science that an external organization be used to allow public and private sector co-funding of strategic environmental, health and safety research. One model explored was the Health Effects Institute, which receives funding from the Environmental Protection Agency (EPA) (both the Office of Research and Development and the Air Office) along with industry to conduct targeted research on the health effects of air pollution.
Is NEHI the most appropriate cross-agency group to assess research gaps, set priorities, and review and direct agency budgets?
I would suggest that the NEHI working group's position under the National Science and Technology Council Committee on Technology places it at an immediate disadvantage in implementing risk-related aspects of the 21st Century Nanotechnology R&D Act, and in particular in ensuring that targeted research informs regulation and other forms of oversight. The paradigms and mechanisms that drive research for effective risk assessment and management differ significantly from those that drive basic science. There is a significant overlap between these two areas—applied risk-research will always build on basic science. But if applied research aimed at assessing and managing risk is approached in the same way as exploratory research, there is a danger that resulting research programs will not be responsive to the needs of regulators, industry and the public. The National Nanotechnology Initiative (NNI) has been extremely successful in stimulating exploratory research across many areas of science, which will underpin new applications and new ways of managing risk. Yet, there are indications that approaches to applied risk-research within the NNI are clouded by following an exploratory research-paradigm. I would highlight just three examples that support this observation:
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The current NEHI Terms of Reference focus on facilitating and supporting bottom-up research programs and strategies—an approach that is ideal for fostering collaborative investigator-driven exploratory research, but is not responsive to assessing research gaps, setting priorities, and reviewing and directing agency budgets.
Current investment in risk-based research is purportedly dominated by the National Science Foundation (NSF)—despite a widely recognized need for targeted risk research beyond the directive of this agency. As nanotechnology moves off the lab bench and into the marketplace, one would expect to see a significant shift in risk-related research funding to mission-driven agencies such as the EPA, the U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), which have direct oversight responsibilities. This is not happening.
The recent NSET research needs document(see footnote 52) refers to current research, which, while conceivably enhancing our understanding of risk in the distant future, has little practical relevance at present. Take, for instance, the cited development of Transmission Electron Aberration-corrected Microscope (TEAM) project within the Department of Energy (DOE).(see footnote 53) From my own research, I can confidently state that, while this is a vital area of research for nano-applications, it is of only secondary importance to increasing our understanding of nano-implications.(see footnote 54)
With the best will in the world, an effective strategic risk-research framework is unlikely to be developed and implemented if those responsible are working within the wrong paradigm, in an inappropriate framework. This is why, in my report on strategic risk research published earlier this year,(see footnote 55) I recommend that a separate interagency group be established that can address these issues within ,an appropriate framework.
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Q2. In your testimony you reported that the Federal Government is spending less on research on environmental and safety issues than the Federal Government claims it is spending. Why do your estimates differ so greatly with the figures reported by the Administration? What do you need to reconcile your figures with the government's accounting?
A2. Based on the considerations outlined below, it is my opinion that the discrepancy between the NSET and the Project on Emerging Nanotechnologies (PEN) figures reflects a rather broad interpretation within NSET of research that is highly relevant to understanding the potential risks of engineered nanomaterials. Because federal agencies within the NNI remain unable to provide information on risk research at the project level, it is not possible to identify the sources of the discrepancy with any certainty.
Funding figures without access to the underlying data are largely meaningless. Understanding the potential risks of nanotechnology is complex, and identifying research that might provide insight is more than an accounting exercise. Because of this, the PEN inventory of health and environmental implications research(see footnote 56) categorizes information in a way that captures the complexity of current research, and provides a resource for anyone interested in planning relevant, coordinated and strategic research. Open-access to the inventory also allows anyone to challenge or validate conclusions drawn from the information it contains. I would encourage the Federal Government to take a similar approach, and indeed would consider this essential for developing strategic research plans that identify and address critical research needs. To achieve this, information must be collated, categorized and made available at the project level. An open accounting of the federal research portfolio would also make it easier for industry to determine where and how it could partner with government to fund risk research, as well as supporting effective international cooperation on strategic research.
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Examining the differences between PEN and NSET risk research estimates
The NSET annual spending figure purportedly reflects research investment where the primary purpose is to understand and address potential risks to health and the environment. Research is either included in or excluded from the reported figures—there is no gray area of research that might have some relevance, but does not have a primary purpose of understanding risk. It must be assumed that interpretation of what constitutes relevant research is undertaken at the agency level and may be based on subjective judgments. Unfortunately, without information on which projects NSET does and does not account for, it is not possible to comment in depth on how this definition has been applied.
In contrast, the PEN inventory categorizes research according to its relevance to understanding risk (high, substantial, some or marginal), allowing an inherently more sophisticated assessment of current activity. In this scheme, highly relevant research is directly focused on addressing risk, while research having lesser relevance might be focused on applications of nanotechnology, general characterization methods or non-engineered nanomaterials. In addition, research into incidental nanomaterials (such as vehicle emissions and naturally occurring nanoparticles) is classified separately from research specifically focused on engineered nanomaterials. This distinction is important—research into the impact of incidental nanomaterials can help inform our understanding of nanotechnology risks, but it is misleading to account for it as being directly relevant to nanotechnology.
From the PEN inventory, it is estimated that the Federal Government invested $11 million on research, which is highly relevant to engineered nanomaterials in 2005 (Table 1). This added sophistication in accounting might explain some of the $28.7 million difference between PEN and NSET estimates. For instance, research on welding fume in the workplace—an incidental nanomaterial—has been included in the PEN inventory as it is useful for understanding purposely made nanomaterials. Yet this research has not been included in the estimated $11 million—precisely because it is not specifically focused on engineered nanomaterials. There is no way of telling at present whether the NSET has included this, and similar research projects, in spending estimates.
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The DOE, Department of Commerce (DOC), USDA and Department of Justice (DOJ) together account for a $3.4 million difference between the PEN and NSET figures. Information on what research DOJ is funding on nanotechnology risk research is not directly available, and is thus not included in the PEN inventory. For the other three agencies, it is likely that research accounted for by NSET as primarily addressing nano-risk was not considered highly relevant in the PEN inventory. For instance, a DOE project led by Dr. Kaufmann on controlling the shape, size and reactivity of metal oxide nanoparticles is categorized as having substantial, but not high relevance to risk in the PEN inventory. Likewise, a NIST project on developing microsphere-based spectroscopic instruments is categorized as having marginal relevance to risk in the PEN inventory. It is unclear whether NSET included these projects in its accounting.
The EPA and the National Institute for Occupational Safety and Health (NIOSH)—two federal agencies charged with supporting research to understand and reduce adverse health and environmental impacts—account for a $2.9 million difference between PEN and NSET figures. Discrepancies associated with EPA may well be due to differences in accounting—the NSET—reported figure for EPA includes a research investment in nanotoxicology grants for the period of fiscal year 2006'fiscal year 2009, while the PEN figure reports mean annual EPA spending on risk-relevant research. Differences in the NIOSH estimates result from the lack of project-specific information being directly available from the agency. In the absence of further information, the reported $3 million per year investment was factored by the number of NIOSH projects in the PEN inventory that are highly relevant to understanding the potential risks of engineered nanomaterials.
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By far the largest discrepancy is with estimated NSF funding—with a difference of $21.5 million per year between NSET and PEN. This is likely due to different interpretations of relevant research. Once again, I can only speculate on why the figures are so different, without NSET providing information at the project level. However, as an agency charged with funding basic research, it is surprising to see NSF purportedly accounting for over 60 percent of research where the primary purpose is to understand and address potential risks to health and the environment—over three times the NSET-reported investment within NIOSH and EPA. This in itself is cause to question the figures.
The PEN inventory classifies many of the NSF projects as relevant to understanding risk, but not highly relevant. For instance, the NSF-funded Center for Biological and Environmental Nanotechnology (CBEN) at Rice University was considered substantially relevant to understanding risk, but the center's focus on applications as well as implications of nanotechnology precluded the research being categorized as highly relevant. Similarly, research into biologically compatible engineered nanoparticles to prevent UV-radiation induced damage was considered to have some relevance to risk, but not to be highly relevant.
Questions submitted by Representative Bart Gordon
Q1. In responses to questions at the hearing, the agency witnesses seemed to be saying the current planning/coordinating mechanism for EHS research based on the NEHI working group will be able to produce an EHS research plan or roadmap, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. Do you believe that there are adjustments that could be made to the way NEHI functions or to the way it is staffed that would allow it to achieve this goal in a timely way?
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A1. From my experience as co-chair of NEHI, my knowledge of the terms of reference of the working group and my observations of the group's activity over the past year, I can only conclude that NEHI will not be able to produce an EHS research plan consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency, within an acceptable time frame. Let me qualify this by stating that the current members of NEHI are extremely well qualified to identify and assess what research needs to be done and by whom if the Federal Government's investment in nanotechnology research is to translate into responsible industries and products. The recent NSET report on research needs attests to this. Yet, NEHI lacks the terms of reference, authority and resources to achieve what is necessary, and members of the group are often juggling many other conflicting commitments to spend the necessary time on ensuring the group functions effectively. There is, as Chairman Boehlert observed during the hearing, a sense of urgency in this task as more nano-based products pour into the marketplace. It is not enough to ask the right questions, they must be asked early enough so that we have time to generate practical answers. Our ability to reap the long-term benefits of our investments in nanotechnology will depend heavily on how we address any emerging risks.
In my response to the first question from Chairman Boehlert (above), I consider three changes that I consider essential, if NEHI is to be effective in ensuring assessing research gaps are assessed, priorities are set, and agency budgets are reviewed and directed. Let me reiterate these changes here:
1. The charter of the NEHI working group must be modified to increase the group's charge and authority to establish and implement a strategic nano-risk research framework, which underpins nanotechnology oversight.
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2. The NEHI working group must have the authority to ensure that appropriate agencies have the resources they need to conduct relevant, effective and coordinated risk research.
3. A full-time director, with appropriate staffing, must oversee the activities of the NEHI working group, with responsibility for developing and implementing a cross-agency strategic risk-research plan. The Director must be seen as an ''honest broker'' with no immediate ties to any government agency. The Director must also have direct access to key decision makers in both the White House and the Office of Management and Budget.
In my opinion, these changes will also enable NEHI to develop a strategic risk research framework, consisting of a cross-agency set of specific research priorities, timelines, and associated funding targets broken out by agency. Without significant changes to the way the group operates, I am extremely pessimistic that we will see an effective strategic research framework emerge that enables federal agencies to operate to the best of their ability when addressing the complex challenges that nanotechnology is raising.
Appendix 2:
Additional Material for the Record
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(Footnote 1 return)
Wilson Center, Project on Emerging Nanotechnologies, ''Nanotechnology: A Research Strategy for Addressing Risk,'' July, 2006. p. 4.
(Footnote 2 return)
Lux Research, ''Taking Action on Nanotech Environmental, Health, and Safety Risks,'' Advisory, May 2006 (NTS–R–06–003) (hereafter cited as ''Taking Action'').
(Footnote 3 return)
Lux Research, ''Sizing Nanotechnology's Value Chain,'' October, 2004.
(Footnote 4 return)
Terms of Reference, Nanotechnology Environmental and Health Implications Working Group Nanoscale Science, Engineering, and Technology Subcommittee Committee on Technology; March, 2005.
(Footnote 5 return)
The National Nanotechnology Initiative: ''Research and Development Leading to a Revolution in Technology and Industry, Supplement to the President's FY 2007 Budget.'' http://www.ostp.gov/nstc/html/NNI%2007%20Budget%20Supplement%20July%202007.pdf
(Footnote 6 return)
Clayton Teague Testimony, November 17, 2005, House Science Committee, p. 3.
(Footnote 7 return)
In addition to the three reports described in detail in this charter, Guy Carpenter & Company, Inc., a leading risk and reinsurance specialist and a part of the Marsh & McLennan Companies, Inc., published a report in August 2006 titled, ''Nanotechnolgy: The Plastics of the 21st Century.'' The report provides businesses and risk managers with an overview of the field and some of the environmental issues that can be expected to arise relating to insurance and government regulation. In another important report issued just before the Science Committee's Nov. 2005 hearing, Innovest, an investment research firm that rates companies on their environmental management and performance, issued a report titled, '' Nanotechnology'' (October 2005), in which it introduced an investment index for investors. The report discusses the market viability of nano-products and materials in light of environmental and safety issues that could play a role in commercialization and in company performance. It also provides an overview of company best practices. The report distills a list of 300 public and private companies found in NanoInvestornews.com down to an index of 15 companies, and a watch list of an additional eight companies. Innovest is tracking the indexed companies and updates its findings for clients.
(Footnote 8 return)
Lux Research, ''Taking Action,'' 2006.
(Footnote 9 return)
Lux Research, ''A Prudent Approach to Nanotech Environmental, Health and Safety Risks.'' May, 2005.
(Footnote 10 return)
The Wilson Center inventory continues to be updated; the most current version is available online at http://www.nanotechproject.org/18. Information from the inventory was included in the November 17, 2005 hearing record.
(Footnote 11 return)
This analysis was performed on the inventory as of November 23, 2005.
(Footnote 12 return)
Wilson Center, Project on Emerging Nanotechnologies, ''Nanotechnology: A Research Strategy for Addressing Risk,'' July, 2006.
(Footnote 13 return)
The Health Effects Institute (HEI) is as an independent, non-profit research organization, chartered in 1980, to provide high-quality, impartial, and relevant science on the health effects of air pollution. Typically, HEI receives half of its core funds from the EPA and half from the worldwide motor vehicle industry. http://www.healtheffects.org
(Footnote 14 return)
Lux Research, ''Sizing Nanotechnology's Value Chain,'' October 2004.
(Footnote 15 return)
Small Wonders, Endless Frontiers: A Review of the National Nanotechnology Initiative, National Research Council/National Academy of Sciences, 2002.
(Footnote 16 return)
Id.
(Footnote 17 return)
Lux Research, ''Sizing Nanotechnology's Value Chain,'' October 2004.
(Footnote 18 return)
Lux Research, ''A Prudent Approach to Nanotech Environmental, Health and Safety Risks.'' May 2005
(Footnote 19 return)
Lux Research's findings on worker exposure are consistent with the concerns expressed in the recent report on the NNI by the President's Council of Advisors on Science and Technology. The report, National Nanotechnology Initiative at Five Years: Assessment and Recommendations of the National Nanotechnology Advisory Panel, is available online at http://www.nano.gov/FINAL–PCAST–NANO–REPORT.pdf.
(Footnote 20 return)
Informed Public Perception of Nanotechnology and Trust in Government, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars is available online at http://www.pewtrusts.com/pdf/Nanotech–0905.pdf.
(Footnote 21 return)
Environmental Defense and American Chemistry Council Nanotechnology Panel, Joint Statement of Principles, Comments on EPA's Notice of Public Meeting on Nanoscale Materials, June 23, 2005. The full statement is available online at http://www.environmentaldefense.org/documents/4857–ACC-ED–nanotech.pdf.
(Footnote 22 return)
In 2003, the Science Committee wrote and held hearings on the 21st Century National Nanotechnology Research and Development Act, which was signed into law on December 3, 2003. The Act authorizes $3.7 billion over four years (FY05 to FY08) for five agencies (the National Science Foundation, the Department of Energy, the National Institute of Standards and Technology, the National Aeronautics and Space Administration, and the Environmental Protection Agency). The Act also: adds oversight mechanisms—an interagency committee, annual reports to congress, an advisory committee, and external reviews—to provide for planning, management, and coordination of the program; encourages partnerships between academia and industry; encourages expanded nanotechnology research and education and training programs; and emphasizes the importance of research into societal concerns related to nanotechnology to understand the impact of new products on health and the environment.
(Footnote 23 return)
The goals of the NNI are to maintain a world-class research and development program; to facilitate technology transfer; to develop educational resources, a skilled workforce, and the infrastructure and tools to support the advancement of nanotechnology; and to support responsible development of nanotechnology.
(Footnote 24 return)
There is of course additional federal funding being spent on fundamental nanotechnology R&D that has the potential to inform future studies on environmental and safety impacts, so the $38.5 million may be a low estimate of the relevant research underway.
(Footnote 25 return)
''Nanotechnology Grand Challenge in the Environment: Research Planning Workshop Report,'' from the workshop held May 8–9, 2003, is available online at http://es.epa.gov/ncer/publications/nano/nanotechnology4-20-04.pdf.
(Footnote 26 return)
The United Kingdom's Royal Society and Royal Academy of Engineering's report ''Nanoscience and Nanotechnologies: Opportunities and Uncertainties'' was published in July 2004 and is available online at http://www.nanotec.org.uk/finalReport.htm
(Footnote 27 return)
NSTC/NSET, July 2006
(Footnote 28 return)
NSF 2001–2006
(Footnote 29 return)
U.S. Congress (2003). 21st Century Nanotechnology Research and Development Act (Public Law 108–153), S.189 Washington DC, 108th Congress, 1st session.
(Footnote 30 return)
Maynard, A.D. (2006). Nanotechnology: A Research Strategy for Addressing Risk, PEN 03 Washington DC, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars. Available at www.nanotechproject.org.
(Footnote 31 return)
NSET (2006). The National Nanotechnology Initiative: Research and Development Leading to a Revolution in Technology and Industry Supplement to the President's FY 2007 Budget, Washington, DC, Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology, National Science and Technology Council.
(Footnote 32 return)
Nanotechnology Health and Environmental Implications: An Inventory of Current Research. www.nanotechproject.org/18 Accessed September 12th 2006.
(Footnote 33 return)
A Nanotechnology Consumer Products Inventory. www.nanotechproject.org/consumerproducts Accessed September 12th 2006.
(Footnote 34 return)
An on-line Project on Emerging Nanotechnologies inventory identifies nearly 300 nanotechnology-based consumer products (www.nanotechproject.org/consumerproducts). These represent the tip of the commercial nanoproduct iceberg. Lux Research estimates that $32 billion worth of nanotechnology-enabled products were sold in 2005 (www.luxresearchinc.com/press/RELEASE–TNR4.pdf).
(Footnote 35 return)
Interagency Working Group on Nanotechnology Environmental and Health Implications (NEHI WG): www.nano.gov/html/society/NEHI.htm Accessed September 12th 2006.
(Footnote 36 return)
Maynard, A.D. (2006). Nanotechnology: A Research Strategy for Addressing Risk, PEN 03 Washington, DC, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars. Based on data published in the Project on Emerging Nanotechnologies inventory of nanotechnology EH&S research (www.nanotechproject.org/18). This figure does not include recent increased EPA investment in nanotechnology risk research.
(Footnote 37 return)
Health Effects Institute (HEI) Website. ''What is the Health Effects Institute.'' Available at www.healtheffects.org/about accessed July 27th 2006.
(Footnote 38 return)
HEI Annual Report 2005, p. 6.
(Footnote 39 return)
HEI Annual Report 2005, p. 6.
(Footnote 40 return)
See the May 2005 Lux Research report ''A Prudent Approach to Nanotech Environmental, Health, and Safety Risks,'' the November 17, 2005 Lux Research written congressional testimony ''Nanotech Environmental, Health, and Safety Risks: Action Needed,'' and the May 2006 Lux Research report ''Taking Action on Nanotech Environmental, Health, and Safety Risks.''
(Footnote 41 return)
For more information on the value of products sold incorporating emerging nanotechnology, see the February 2006 Lux Research report ''How Industry Leaders Organize for Nanotech Innovation.''
(Footnote 42 return)
This testimony focuses on a specific class of nanomaterials, namely nanoparticles—purposefully engineered bits of matter size-dependent properties and sub-100 nm dimensions. They may either be miniature chunks of established materials (like Nanophase's nanoscale zinc oxide, used in sunscreens), or highly ordered structures that only form at the nanoscale (like CarboLex's single-walled carbon nanotubes, which may be soon used in flat-panel displays). We specifically do not address bulk materials with nanostructured features (like Apollo Diamond's nanostructured synthetic diamond) or nanoporous materials that have nano-sized holes (like Argonide's nanoporous ceramic water filtration media) because these materials appear unlikely on current evidence to pose novel EHS risks. We also do not address ''incidental nanoparticles'' which have nanoscale dimensions but have not been purposefully engineered, like the ultra-fine carbon particles emitted in diesel exhaust. It's important to note that ''nanotechnology does not equal nanoparticles'' and that many nanotech applications, like a wide variety of next-generation semiconductor technologies, do not involve the use of any nanoparticles at all.
(Footnote 43 return)
''[60]Fullerene is a Powerful Antioxidant in Vivo with No Acute or Subacute Toxicity.'' Gharbi, N.; Pressac, M.; Hadchouel, M.; Szwarc, H; Wilson, S.R.; Moussa, F. Nano Letters 2005, 5, 2578–85, and ''The Differential Cytotoxicity of Water-Soluble Fullerenes.'' Sayes, C.M. ; Fortner, J.D.; Guo, W.; Lyon, D.; Boyd, A.M.; Ausman, K.D.; Tao, Y.J.; Sitharaman, B.; Wilson, L.J.; Hughes, J.B.; West, J.L.; Colvin, V.L. Nano Letters 2004, 4, 1881–1887.
(Footnote 44 return)
''The public and nanotechnology: How citizens make sense of emerging technologies.'' Scheufele, D.A., Lewenstein, B.V. J. Nanoparticle Res. 2005, 7, 659–667.
(Footnote 45 return)
''Nanotech's big issue,'' Gewin, V., Nature 2006, 443, 137.
(Footnote 46 return)
See the May 2005 Lux Research report ''A Prudent Approach to Nanotech Environmental, Health, and Safety Risks'' and the November 17, 2005 Lux Research written congressional testimony ''Nanotech Environmental, Health, and Safety Risks: Action Needed.''
(Footnote 47 return)
Science Citation Index as of May 21, 2005; search terms ''(toxici* OR toxico*) AND (X)'', where X = (quantum dot OR nanopartic* OR nanotub* OR fulleren* OR nanomaterial* OR nanofib* OR nanotech* OR nanocryst* OR nanocomposit* OR dendrimer*) or X = (poly* OR copoly* ANDNOT polychlorinated).
(Footnote 48 return)
The ICON database can be found at http://icon.rice.edu/centersandinst/icon/resources.cfm?doc–id=8597. The ILSI report was published as ''Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy'' OberdoAE4rster, G.; et al. Particle and Fibre Toxicology 2005, 2:8. Other review article used were: (a) ''Nanotoxicology: An Emerging Discipline Evolving from Studies of Ultra-fine Particles.'' OberdoAE4rster, G.; OberdoAE4rster, E.; OberdoAE4rster, J.; Env. Health Perspect. 2005, 113, 823–839. (b) ''Airborne nanostructured particles and occupational health.'' Maynard, A.D.; Kuempel, E.D. J. Nanoparticle Res. 2005, 7, 587–614. (c) ''Industrial application of nanomaterials—chances and risks.'' Luther, W., ed. Future Technologies Division, VDI Technologiezentrum (sponsored by the EC Nanosafe program). With over 1300 records in the ICON database, readers may be surprised that so few are used in our analysis. ICON's database includes many articles on incidentally-produced nanoparticles (such as those found in diesel exhaust or generated by welding), as well as articles on environmental or health applications of nanomaterials, such as the use of iron nanoparticles in wastewater remediation or polymer nanoparticles in drug delivery. Such studies can contain helpful information on hazard or exposure, but are of less direct use for trying to understand the risks of their own materials than those that squarely address EHS questions.
(Footnote 49 return)
OberdoAE4rster, G; Ferin, J; Lehnert, B.E. Environ. Health Perspect. 1994, 102, Supplement 5, 173–179; ''Pulmonary Instillation Studies with Nanoscale TiO Rods and Dots in Rats: Toxicity Is Not Dependent upon Particle Size and Surface Area.'' Warheit, D.B.; Webb, T.R.; Sayes, C.M.,; Colvin, V.L.; Reed, K.L. Toxicol. Sci. 2006, 91, 227–236; Warheit, D.B., personal communication.
(Footnote 50 return)
A key exception to this rule lies with start-up companies. As we have previously stated to the House Committee on Science, start-ups are both generally the earliest commercial developers of new nanoparticles and also the parties least likely to be able to afford expensive toxicology studies. As long as these dynamics hold, there will be a market failure that only government can correct. We continue to believe that a market-based mechanism, which would require companies receiving government funding for products that incorporate nanoparticles to submit their materials for anonymous testing as a condition of the grant, is the most efficient way to ensure that scarce government research funds are allocated efficiently to materials of greatest commercial interest. Such a mechanism would place a new requirement on small businesses receiving Small Business Innovation Research and/or Small Business Technology Transfer grants, but because the only requirement is the submission of a small amount of material for anonymous testing with no financial or onerous documentation requirements, it does not seem to our layman's eyes to represent an undue burden.
(Footnote 51 return)
Bennett, P.; Calman, K. Risk Communication and Public Health. Oxford University Press, Oxford, 1999.
(Footnote 52 return)
NSET. 2006. Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials. Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council. September.
(Footnote 53 return)
Ibid, p. 15.
(Footnote 54 return)
Maynard, A.D. 1995. ''The application of electron energy-loss spectroscopy to the analysis of ultra-fine aerosol particles.'' J. Aerosol Sci. 26(5): 757–777; Maynard, A.D. and L.M. Brown. 2000. ''Overview of methods for analysing single ultra-fine particles.'' 358(1775): Philosophical Transactions of the Royal Society of London Series a-Mathematical Physical and Engineering Sciences. 2593–2609; Maynard, A.D., Y. Ito, et al. 2004. ''Examining elemental surface enrichment in ultra-fine aerosol particles using analytical Scanning Transmission Electron Microscopy,'' Aerosol Sci. Tech. 38: 365–381.
(Footnote 55 return)
Maynard, A.D. 2006. Nanotechnology: A Research Strategy for Addressing Risk. Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, July. Available at: http://www.nanotechproject.org/reports.
(Footnote 56 return)
PEN. 2005. Nanotechnology Health and Environmental Implications: An Inventory of Current Research. Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars. Available at: http://www.nanotechproject.org/18/esh-inventory.